Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau

This study has been completed.
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00426439
First received: January 23, 2007
Last updated: January 2, 2011
Last verified: January 2011
  Purpose

This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.


Condition Intervention Phase
Malaria, Falciparum
Drug: Chloroquine
Drug: Artemether-lumefantrine (Coartem)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau.

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Parasite reappearance rate, [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • genetic markers of resistance [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • recrudescence and re-infection rates [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Hospitalisation during follow-up [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Haemoglobin changes [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Coartem
Treatment of documented malaria in children following the dosages recommended by the manufacturer.
Drug: Chloroquine
Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.
Drug: Artemether-lumefantrine (Coartem)
Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
Other Name: Brand name: Coartem.
Active Comparator: 2 Chloroquine
The antimalarial actually used in Guinea-Bissau is the dosage of 50 mg/kg given twice a day for 3 days.
Drug: Chloroquine
Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.
Drug: Artemether-lumefantrine (Coartem)
Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
Other Name: Brand name: Coartem.

Detailed Description:

This study compares treatment of uncomplicated malaria in children in Guinea-Bissau with artemether-lumefantrine (Coartem) with that of treatment with chloroquine 50 mg/kg. Furthermore, the genetic basis of anti-malarial resistance in Guinea-Bissau will be studied by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial. We also intend to study whether the recent report that chloroquine sensitive parasites are selected at recrudescence after Coartem is confirmed in Bissau.

Following consent to participate, children visiting one of the Health Centres in the study area with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the treatment groups. The treatment is given supervised by one of the health workers and malaria film taken on day 2 and 3. The children are visited and malaria films obtained once weekly until day 70. On day seven, 100 microliter of capillary blood are drawn for analyses of analyses of drug concentrations in whole blood. On inclusion and whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis. On the day of inclusion, on day 42 and on day 70 the haemoglobin level is measured.

If parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. During the study parents are recommended to bring the child to the health centre in case of any illness. Participating children will be examined and treated free of charge. The opposite study drug will be used for re-treatment of children in case of recrudescence, and the child will be followed as previously planned.

The results from this study could be used for the planning of the recommendations for treatment of malaria in Guinea-Bissau. It will provide the National Malaria Programme with information of the efficacy of Coartem before it is implemented.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children presenting at one of the health centres in the study area
  • Symptoms suggestive of malaria
  • At least 20 P.falciparum parasites per 200 leucocytes
  • Living in the study area (to enable follow-up)

Exclusion Criteria:

  • Danger signs
  • By the responsible doctor evaluated to need to be transferred to the national hospital as an in-patient
  • Previous idiosyncratic reactions to any of the study drugs
  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: NCT00426439

Locations
Guinea-Bissau
Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Study Director: Peter Aaby Bandim Health Project
  More Information

No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Poul-Erik Kofoed, Bandim Heath Project
ClinicalTrials.gov Identifier: NCT00426439     History of Changes
Other Study ID Numbers: PSB-2006-Coartem
Study First Received: January 23, 2007
Last Updated: January 2, 2011
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
malaria
Plasmodium falciparum
children
Guinea-Bissau
artemether
lumefantrine
chloroquine
Coartem

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Lumefantrine
Artemether
Artemether-lumefantrine combination
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
Antifungal Agents
Coccidiostats

ClinicalTrials.gov processed this record on September 16, 2014