Lapdap and Coartemether for Uncomplicated Malaria

Malaria Clinical Trial

Official title:

Randomized Trial of the Safety and Effectiveness of Lapdap and Coartemether for Uncomplicated Malaria in Operational Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118794
• Other study ID #: SCC975
• Secondary ID: SCC975
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: January 31, 2006
• Start date: September 2004
• Est. completion date: June 2005

Study information

• Verified date: January 2005
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: Department of State for Health and Social Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Chlorproguanil-dapsone (Lapdap)

• Lumefantrine-artemether (Coartemether )

Locations

Country	Name	City	State
Gambia	Medical Research Council Laboratories	Banjul

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Medical Research Council, National Malaria Control Programme, The Gambia

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical failure by day 28
Secondary	Incidence of severe anaemia by day 28
Secondary	Compliance
Secondary	Incidence of adverse events
Secondary	Parasitological failure by day 28
Secondary	Clinical and parasitological failure rates by day 14
Secondary	Fall in Hb of 2g/dl or more from screening value