Lapdap and Coartemether for Uncomplicated Malaria

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
National Malaria Control Programme, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00118794
First received: July 1, 2005
Last updated: January 31, 2006
Last verified: January 2005
  Purpose

Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.


Condition Intervention Phase
Malaria
Drug: Chlorproguanil-dapsone (Lapdap)
Drug: Lumefantrine-artemether (Coartemether )
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of the Safety and Effectiveness of Lapdap and Coartemether for Uncomplicated Malaria in Operational Settings

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Clinical failure by day 28

Secondary Outcome Measures:
  • Incidence of severe anaemia by day 28
  • Compliance
  • Incidence of adverse events
  • Parasitological failure by day 28
  • Clinical and parasitological failure rates by day 14
  • Fall in Hb of 2g/dl or more from screening value

Estimated Enrollment: 1200
Study Start Date: September 2004
Estimated Study Completion Date: June 2005
Detailed Description:

Patients with uncomplicated malaria will be recruited at three health centres in the Gambia. Children aged 6 months to 10 years presenting with a history of illness, who have a fever or recent history of fever, will be screened; those with uncomplicated malaria, a positive blood smear with a parasite density of 500 to 200,000 parasites/µl, monoinfection with P. falciparum, and a packed cell volume of >=20%, will be invited to enroll into the study and if consent is given, will be randomized to receive three daily doses of lapdap, or a six-dose course of Coartem. The first dose will be given by the mother under direct observation by the dispensing nurse; subsequent doses will be given at home unsupervised. Children will be followed up actively three times; on day 3, to assess adherence to the treatment regimen, and on days 14 and 28, to assess parasitological and haematological recovery. The mother/caregiver of the child will be encouraged to bring the child to the clinic if the child does not improve or if she is concerned about the child’s health. On day 3, the parent/caregiver will be visited at home (after the last dose should have been taken) in order to check for any leftover medication, and to ask about compliance and adverse reactions. A finger prick blood sample will be taken for Hb measurement by haemocue in the field and for a filter paper sample for measurement of drug concentration. The investigators will employ a longitudinal randomized design, whereby subsequent episodes of malaria will be treated according to the original randomization. This will enable better assessment of cumulative effects of repeated treatments on anaemia and on tolerability. Since patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap, the investigators will determine the G6PD genotype and enzymatic activity, in order to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presentation at health centre with febrile illness
  • monoinfection with P falciparum
  • parasitaemia >=500/microlitre
  • fever or history of fever

Exclusion Criteria:

  • signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
  • severe malnutrition
  • clinically evident concomitant disease
  • PCV <20%
  • history of allergy to the study medications
  • residence outside the study area and hence difficult to follow up
  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: NCT00118794

Locations
Gambia
Medical Research Council Laboratories
Banjul, Gambia, POBOX273
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Medical Research Council
National Malaria Control Programme, The Gambia
Investigators
Principal Investigator: Paul J Milligan, BSc MSc PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Sam K Dunyo, MD PhD Medical Research Council
  More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00118794     History of Changes
Other Study ID Numbers: SCC975, SCC975
Study First Received: July 1, 2005
Last Updated: January 31, 2006
Health Authority: Gambia: Department of State for Health and Social Welfare

Keywords provided by London School of Hygiene and Tropical Medicine:
uncomplicated malaria
G6PD deficiency
haemolytic anaemia
Lapdap
Artemsinin based combination treatment
compliance
pragmatic trials

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Artemether-lumefantrine combination
Chlorproguanil
Lumefantrine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014