Chloroquine and Post Malaria Anaemia Study (CQ-PMA)

This study has been completed.
Sponsor:
Information provided by:
Medical Research Council Unit, The Gambia
ClinicalTrials.gov Identifier:
NCT00473837
First received: May 15, 2007
Last updated: January 29, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Medical Research Council Unit, The Gambia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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:

  1. Children aged 12 months to 6 years; and
  2. 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
  3. 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:

  1. Refusal of parent or guardian to give consent to the child's participation in the study
  2. Inability of the subjects to take oral medications
  3. Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density
  4. Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly
  5. Children with known haemoglobinopathy
  6. Children with a weight for height Z score below -3SD of WHO/NCHS standard
  7. Enrolment in another research project
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473837

Sponsors and Collaborators
Medical Research Council Unit, The Gambia
Investigators
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 September 18, 2014