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Sponsored by: |
Medical Research Council Laboratories, Gambia |
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Information provided by: | Medical Research Council Laboratories, Gambia |
ClinicalTrials.gov Identifier: | NCT00473837 |
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 either standard anti-malarial treatment (chloroquine plus sulphadoxine/pyrimethamine) or artemisinine combination therapy. Three days after commencement of antimalarial treatment, the children in each of the two arms will be further randomised to receive either weekly chloroquine or weekly placebo. By comparing the curve of haemoglobin change between day 3 and one month follow-up 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 3 months follow-up 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
Condition | Intervention |
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Malaria Anaemia |
Drug: Chloroquine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Chloroquine as a Therapeutic Option for Mild Post Malaria Anaemia |
Estimated Enrollment: | 260 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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S1: Experimental
Subjects are initially treated with chloroquine plus sulphadoxine-pyrimethamine to clear the parasiteamia then continued with weekly chloroquine till day 90
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Drug: Chloroquine
Chloroquine: 10mg/kg once daily for three days, followed by weekly treatment of 7.5mg/kg for three months Sulphadoxine/Pyrimethamine: ½ tablets per 10kg body weight given once on Day 1 Co-artemether: A total of six doses given over 3 days - a stat dose, then 8 hours later followed by twice daily dose for the next two days. The number of tablets will depend on the weight of the child as follows: 5 to 14.99 kg - one tablet per dose; 15 to 24.99kg - 2 tablets per dose; and 25 to 34.99kg - 3 tablets per dose.
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A1: Experimental
Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
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Drug: Chloroquine
Chloroquine: 10mg/kg once daily for three days, followed by weekly treatment of 7.5mg/kg for three months Sulphadoxine/Pyrimethamine: ½ tablets per 10kg body weight given once on Day 1 Co-artemether: A total of six doses given over 3 days - a stat dose, then 8 hours later followed by twice daily dose for the next two days. The number of tablets will depend on the weight of the child as follows: 5 to 14.99 kg - one tablet per dose; 15 to 24.99kg - 2 tablets per dose; and 25 to 34.99kg - 3 tablets per dose.
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S0: Placebo Comparator
Subjects initially treated with chloroquine plus sulphadoxine-pyrimethamine and then continued on weekly placebo till day 90
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Drug: Placebo |
A0: Placebo Comparator
Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
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Drug: Placebo |
Ages Eligible for Study: | 12 Months to 72 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be:
Exclusion Criteria:
Contact: Chidi V Nweneka, MSc | +2209957634 | cnweneka@mrc.gm |
Gambia, West Kiang District | |
Keneba Field Station | Recruiting |
Banjul, West Kiang District, Gambia, 00000 | |
Contact: Chidi V Nweneka, MSc. +220 9957634 cnweneka@mrc.gm | |
Contact: Sophie Moore, PhD +220 9963991 sophie.moore@lshtm.ac.uk | |
Principal Investigator: Chidi V Nweneka, MSc | |
Sub-Investigator: Conor P Doherty, MRCP, MD | |
Sub-Investigator: Lawrence T Weaver, DSc, FRCP | |
Sub-Investigator: Andrew Prentice, PhD | |
Sub-Investigator: Sharon Cox, PhD | |
Sub-Investigator: Sophie Moore, PhD | |
Sub-Investigator: Tony Fulford, PhD | |
Sub-Investigator: Climent Casals, PhD |
Principal Investigator: | Chidi V Nweneka, MSc. | Medical Research Council Laboratories, Gambia |
Study Director: | Sophie Moore, PhD | Medical Research Council Laboratories, Gambia |
Responsible Party: | Medical Research Council Labs, The Gambia ( Dr Chidi V Nweneka, Research Clinician ) |
Study ID Numbers: | SCC1076 |
Study First Received: | May 15, 2007 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00473837 |
Health Authority: | Gambia: MRC Ethics Committee |
malaria anaemia chloroquine iron delocalisation macrophages |
Pyrimethamine Protozoan Infections Hematologic Diseases Chloroquine diphosphate Anemia Chloroquine |
Parasitic Diseases Malaria Sulfadoxine Iron Artemether |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Filaricides Coccidiosis Physiological Effects of Drugs Anthelmintics Pharmacologic Actions Antimalarials Antiparasitic Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Amebicides Analgesics Antirheumatic Agents Central Nervous System Agents Antinematodal Agents |