CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Chloroquine +1 moredrug
Likely dose
Chloroquine 60mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00473837
NCT00473837N/ACompleted

Chloroquine as a Therapeutic Option for Mild Post Malaria Anaemia

Medical Research Council Unit, The Gambia·interventional·Posted May 16, 2007·Updated Oct 13, 2014

In Brief

A clinical study evaluating Chloroquine and Placebo for Malaria Anaemia. Completed, enrolled 96 participants.

Detailed Summary

The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the mainstay of management of moderate and severe anaemia; however the management of mild anaemia (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of chloroquine could make it a useful drug in the management of mild post malaria anaemia. To test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether . All children with parasitologic cure after three days on treatment will be randomised to receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron loading and release in acute clinical malaria. By comparing the haemoglobin change between day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of action by determining parasite clearance, peripheral cytokine production and iron flux

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria Anaemia
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2007
Enrollment StartJul 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.1 years ago

Interventions

Chloroquinedrug

This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days

Placebodrug

The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul