NCT00372541

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

September 6, 2006

Last Update Submit

July 23, 2010

Conditions

Pneumonia

Keywords

ceftriaxonechloramphenicolsevere pneumoniachildren

Outcome Measures

Primary Outcomes (1)

  • Mortality from severe pneumonia by 7th day of treatment

Secondary Outcomes (3)

  • Time to normalisation of respiratory rate

  • Time to normalisation temperature

  • Time to normalisation of oxygen saturation

Interventions

ceftriaxoneDRUG

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing
  • Consent from parent/carer

You may not qualify if:

  • Children with severe Asthmatic attack
  • Allergy to any of the study drugs
  • Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Paediatrics and Child Health, Mulago Hospital

Kampala, East Africa, 256, Uganda

Location

Department of Paediatrics and Child Health, Makerere University

Kampala, Kampala, P O 7072, Uganda

Location

Department of paediatrics and child Health,Makerere university

Kampala, Kampala, P O 7072, Uganda

Location

Department of Paediatrics and Child, Makerere University

Kampala, Kampala, P O 7072, Uganda

Location

Related Publications (4)

  • 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. doi: 10.1007/BF02828108.

    PMID: 15572814BACKGROUND

  • 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. doi: 10.1179/027249304225019046.

    PMID: 15479572BACKGROUND

  • Bjerre LM, Verheij TJ, Kochen MM. Antibiotics for community acquired pneumonia in adult outpatients. Cochrane Database Syst Rev. 2004;(2):CD002109. doi: 10.1002/14651858.CD002109.pub2.

    PMID: 15106168BACKGROUND

  • 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. doi: 10.1093/jac/dkh207.

    PMID: 15150184BACKGROUND

MeSH Terms

Conditions

Pneumonia

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Cordelia M Katureebe, MBCHB

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

UG(4)