Chloroquine and Post Malaria Anaemia Study (CQ-PMA)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Malaria Anaemia |
Drug: Chloroquine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Chloroquine as a Therapeutic Option for Mild Post Malaria Anaemia |
- Changes in haemoglobin concentration from day 3 post treatment of malaria episode to day 90 in the weekly chloroquine and placebo arms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Curve of Hb change between day 3 and day 30 in the two placebo arms; changes in markers of iron status, measures of inflammation, and Hb response between day 3 and day 30, and between day 3 and day 90 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 96 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A1
Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
|
Drug: Chloroquine
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
|
|
Placebo Comparator: A0
Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
|
Drug: Placebo
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
|
Show Detailed Description Eligibility| 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:
- Children aged 12 months to 6 years; and
- History of fever in the preceding 48 hours or a measured temperature > 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and
- Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb).
Exclusion Criteria:
- Refusal of parent or guardian to give consent to the child's participation in the study
- Inability of the subjects to take oral medications
- Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density
- Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly
- Children with known haemoglobinopathy
- Children with a weight for height Z score below -3SD of WHO/NCHS standard
- Enrolment in another research project
Contacts and Locations| Principal Investigator: | Chidi V Nweneka, MSc. | Medical Research Council Unit, The Gambia |
| Study Director: | Sophie Moore, PhD | Medical Research Council Unit, The Gambia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Chidi V Nweneka, Research Clinician, Medical Research Council Labs, The Gambia |
| ClinicalTrials.gov Identifier: | NCT00473837 History of Changes |
| Other Study ID Numbers: | SCC1076 |
| Study First Received: | May 15, 2007 |
| Last Updated: | January 29, 2010 |
| Health Authority: | Gambia: Department of State for Health and Social Welfare |
Keywords provided by Medical Research Council Unit, The Gambia:
|
malaria anaemia chloroquine iron delocalisation macrophages |
Additional relevant MeSH terms:
|
Anemia Malaria Hematologic Diseases Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013