Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

July 23, 2010 updated by: Makerere University

Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda, P O 7072
        • Department of paediatrics and child Health,Makerere university
      • Kampala, Uganda, P O 7072
        • Department of Paediatrics and Child Health, Makerere University
      • Kampala, Uganda, P O 7072
        • Department of Paediatrics and Child, Makerere University
    • East Africa
      • Kampala, East Africa, Uganda, 256
        • Department of Paediatrics and Child Health, Mulago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality from severe pneumonia by 7th day of treatment

Secondary Outcome Measures

Outcome Measure
Time to normalisation of respiratory rate
Time to normalisation temperature
Time to normalisation of oxygen saturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

  • Principal Investigator: Cordelia M Katureebe, MBCHB, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (ESTIMATE)

September 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD1120041348U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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