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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-257zbc Study of the effect of a new treatment with antibiotic in babies with brochiolitis.


                                Date of registration:
                                
                                    01/04/2012                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    01/04/2012                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Using azithromycin to reduce bronchiolitis length of hospital stay in infants.

                                        

                                        
pt-br

                                        
Avaliação da resposta ao tratamento com azitromicina em lactentes internados com bronquiolite viral aguda.

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
  • 
                                        UTN code: 
                                        U1111-1122-3127
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Study of the effect of a new treatment with antibiotic in babies with brochiolitis.
    
                                                
    
                                                    
    pt-br
    
                                                    
    Avaliação do efeito da de um novo tratamento com antibiótico em bebês com bronquiolite.
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
    • 
                                                    09/04678
      
                                                    Issuing authority:
                                                    CEP-PUCRS
                                                
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    • 
                                                    0171.0.002.000-09
      
                                                    Issuing authority:
                                                    SISNEP
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Fundação de Amparo a Pesquisa do Estado do Rio Grande do Sul
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Fundação de Amparo a Pesquisa do Estado do Rio Grande do Sul
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Acute viral bronchiolitis
    
                                                
    
                                                
    pt-br
    
                                                
    Bronquiolite viral aguda
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                                                                
    
                                                
    en
    
                                                
    
                                                    J00-J99
                                                    X - Diseases of the respiratory system
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    J00-J99
                                                    X - Doenças do aparelho respiratório
                                                
    
                                                
                                            
     
    
                                    
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    Specific descriptors:
    
                                                                                
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Treatment with azythromycin per oral.
    
                                                
    
                                                
    pt-br
    
                                                
    Tratamento com azitromicina via oral.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        D02.540.505.250.050
                                                        Azithromycin
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        D02.540.505.250.050
                                                        Azitromicina
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        D02.540.505.250.050
                                                        Azitromicina
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                recruiting
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        09/01/2010                                            (mm/dd/yyyy)
                                        

                                    
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                                        Date last enrollment:
                                        
                                            09/01/2011                                            (mm/dd/yyyy)
                                        
                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                150
                                                -
                                                1 W
                                                12 M
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Infants younger than 12 months, with diagnosis of acute bronchiolitis and hospitalization for at least 24 hours.
    
                                                
    
                                                
    pt-br
    
                                                
    Lactentes com menos de 1 ano, com diagnóstico de bronquiolite aguda e internação hospitalar por pelo menos 24hs.
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Chronic lung disease, cystic fibrosis, congenital heart diseases and previous use of macrolides.
    
                                                
    
                                                
    pt-br
    
                                                
    Doença pulmonar crônica, fibrose cística, cardiopatia congênita e uso prévio de antibióticos macrolídeos.
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                treatment
                                                parallel
                                                2
                                                double-blind
                                                randomized-controlled
                                                2
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        Length of hospitalization: number of days of hospitalization, mesuared by date of discharge - date of hospitalization.
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Tempo de hospitalização: Número de dias em que o paciente ficou hospitalizado medido pela data da alta - data da internação.
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
    en
    
                                                
    
                                                    Length of need of oxygen therapy: number of days of oxygen use, mesuared by the day when oxygen prescription was cancelled - first day of oxygen prescription.
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Tempo de uso de oxigêncio: Número de dias em que o paciente ficou recebeu O2, medido pela data da em que o O2 foi suspenso - primeiro dia da prescrição.
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Leonardo Araujo Pinto
                                                
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                                                            Address:
                                                            Avenida Ipiranga 6690, Hospital São Lucas, 2o andar, IPB
                                                        
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                                                            City: 
                                                            Porto Alegre / Brazil
                                                        
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                                                            Zip code:
                                                            90610-000
                                                        
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                                                    Phone:
                                                    51 3320-300, R2313
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    PUCRS
                                                
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                                                    Full name:
                                                    Renato Tetelbom Stein
                                                
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                                                            Address:
                                                            Av. Ipiiranga 6690
                                                        
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                                                            City: 
                                                            Porto Alegre / Brazil
                                                        
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                                                            Zip code:
                                                            90610000
                                                        
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                                                    Phone:
                                                    51-33364211
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    PUCRS
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Leonardo Araujo Pinto
                                                
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                                                            Address:
                                                            Avenida Ipiranga 6690, Hospital São Lucas, 2o andar, IPB
                                                        
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                                                            City:
                                                            Porto Alegre / Brazil
                                                        
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      • 
                                                            Zip code:
                                                            90610-000
                                                        
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    • 
                                                    Phone:
                                                    51 3320-300, R2313
                                                
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                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    PUCRS
                                                
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    • 
                                                    Full name:
                                                    Renato Tetelbom Stein
                                                
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      • 
                                                            Address:
                                                            Av. Ipiiranga 6690
                                                        
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      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
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      • 
                                                            Zip code:
                                                            90610000
                                                        
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                                                    Phone:
                                                    51-33364211
                                                
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                                                    Email:
                                                    
                                                
      • 
                                                
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                                                    Affiliation:
                                                    PUCRS
                                                
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                                        Site contact

                                        
      
                                                                                            
    • 
                                                    Full name:
                                                    Leonardo Araujo Pinto
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Avenida Ipiranga 6690, Hospital São Lucas, 2o andar, IPB
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            90610-000
                                                        
        • 
                                                    
      
                                                
      • 
                                                
    • 
                                                    Phone:
                                                    51 3320-300, R2313
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    PUCRS
                                                
      • 
                                                                                            
    • 
                                                    Full name:
                                                    Renato Tetelbom Stein
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Av. Ipiiranga 6690
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            90610000
                                                        
        • 
                                                    
      
                                                
      • 
                                                
    • 
                                                    Phone:
                                                    51-33364211
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    PUCRS
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


Total de Ensaios Clínicos 17441.



Existem 8770 ensaios clínicos registrados.



Existem 4835 ensaios clínicos recrutando.



Existem 90 ensaios clínicos em análise.



Existem 5882 ensaios clínicos em rascunho.







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