CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 348 target
Drug / intervention
ceftriaxonedrug
Likely dose
Not stated in record
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Search/NCT00372541
NCT00372541Phase 3Completed

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

Makerere University·interventional·Posted Sep 7, 2006·Updated Jul 26, 2010

In Brief

A Phase 3 clinical trial evaluating ceftriaxone for Pneumonia. Completed, enrolled 348 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesUganda
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2006
Enrollment StartSep 1, 2006
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.8 years ago

Interventions

ceftriaxonedrug