Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

Sponsor

Makerere University (Other)

Overall Status

Completed

CT.gov ID

NCT00372541

Collaborator

(none)

348

Enrollment

Locations

5.9

Duration (Months)

Patients Per Site

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: ceftriaxone	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

348 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Paediatrics and Child Health, Mulago Hospital	Kampala	East Africa	Uganda	256
2	Department of Paediatrics and Child Health, Makerere University	Kampala		Uganda	P O 7072
3	Department of paediatrics and child Health,Makerere university	Kampala		Uganda	P O 7072
4	Department of Paediatrics and Child, Makerere University	Kampala		Uganda	P O 7072