Pneumonia Clinical Trial
Official title:
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial
Verified date | July 2010 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
Acute lower respiratory tract infections are a leading cause of morbidity and mortality in
sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous
chloramphenicol for the treatment of severe pneumonia in children aged less than five years.
However, up to 20% of children fail treatment due to the emergence of resistance by
bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is
reported to be efficacious in the treatment of severe pneumonia. However the high cost of
ceftriaxone is too prohibitive to allow for its routine use in resource constrained
countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the
treatment of severe pneumonia in children under five.
We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75
mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those
who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).
Status | Completed |
Enrollment | 348 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing - Consent from parent/carer Exclusion Criteria: - Children with severe Asthmatic attack - Allergy to any of the study drugs - Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic treatment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Uganda | Department of Paediatrics and Child Health, Makerere University | Kampala | |
Uganda | Department of Paediatrics and Child Health, Mulago Hospital | Kampala | East Africa |
Uganda | Department of paediatrics and child Health,Makerere university | Kampala | |
Uganda | Department of Paediatrics and Child, Makerere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University |
Uganda,
Bakeera-Kitaka S, Musoke P, Downing R, Tumwine JK. Pneumocystis carinii in children with severe pneumonia at Mulago Hospital, Uganda. Ann Trop Paediatr. 2004 Sep;24(3):227-35. — View Citation
Bjerre LM, Verheij TJ, Kochen MM. Antibiotics for community acquired pneumonia in adult outpatients. Cochrane Database Syst Rev. 2004;(2):CD002109. Review. Update in: Cochrane Database Syst Rev. 2009;(4):CD002109. — View Citation
Cetinkaya F, Gogremis A, Kutluk G. Comparison of two antibiotic regimens in the empirical treatment of severe childhood pneumonia. Indian J Pediatr. 2004 Nov;71(11):969-72. — View Citation
Ortiz-Ruiz G, Vetter N, Isaacs R, Carides A, Woods GL, Friedland I. Ertapenem versus ceftriaxone for the treatment of community-acquired pneumonia in adults: combined analysis of two multicentre randomized, double-blind studies. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii59-66. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality from severe pneumonia by 7th day of treatment | |||
Secondary | Time to normalisation of respiratory rate | |||
Secondary | Time to normalisation temperature | |||
Secondary | Time to normalisation of oxygen saturation |
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