Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

This study has been completed.
Sponsor:
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00372541
First received: September 6, 2006
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

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).


Condition Intervention Phase
Pneumonia
Drug: ceftriaxone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Mortality from severe pneumonia by 7th day of treatment

Secondary Outcome Measures:
  • Time to normalisation of respiratory rate
  • Time to normalisation temperature
  • Time to normalisation of oxygen saturation

Estimated Enrollment: 348
Study Start Date: September 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

A recent report from the World health Organization showed pneumonia was the leading cause of death in children less than 5 years. WHO recommends intravenous Chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. Ceftriaxone 75mg/kg daily is the second line drug.

The efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. A study comparing penicillin G plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in Turkey found that both drugs were equally effective in normalization of the outcome parameters. A recent Cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia.

The objective of this study it to compare the efficacy of Ceftriaxone versus Chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to Mulago hospital.

This will be a double- blinded randomized controlled trial. Three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372541

Locations
Uganda
Department of Paediatrics and Child Health, Mulago Hospital
Kampala, East Africa, Uganda, 256
Department of Paediatrics and Child Health, Makerere University
Kampala, Uganda, P O 7072
Department of Paediatrics and Child, Makerere University
Kampala, Uganda, P O 7072
Department of paediatrics and child Health,Makerere university
Kampala, Uganda, P O 7072
Sponsors and Collaborators
Makerere University
Investigators
Principal Investigator: Cordelia M Katureebe, MBCHB Makerere University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00372541     History of Changes
Other Study ID Numbers: HD1120041348U
Study First Received: September 6, 2006
Last Updated: July 23, 2010
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
ceftriaxone
chloramphenicol
severe pneumonia
children

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Chloramphenicol
Chloramphenicol succinate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014