Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum

Asymptomatic P.Falciparum Malaria Clinical Trial

Official title:

Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289250
• Other study ID #: SCC867
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2006
• Last updated: February 28, 2006
• Start date: May 2001
• Est. completion date: December 2001

Study information

• Verified date: December 2002
• 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

Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.

Description:

Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• P.falciparum parasitaemia above 20/uL

• Resident in one of the four study villages

Exclusion Criteria:

• Fever

• Any other sign of clinical malaria

• Pregnancy

• Weight <5kg

• History of hypersensitivity to any of the study drugs

• Treatment with any of the study drugs in the last 4 weeks

Study Design

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

Related Conditions & MeSH terms

• Asymptomatic P.Falciparum Malaria
• Malaria, Falciparum

Intervention

Drug:
• Sulfadoxine-pyrimethamine

• Sulfadoxine-pyrimethamine plus artesunate

Locations

Country	Name	City	State
Gambia	Medical Reseearch Council Laboratories The Gambia	Banjul

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Medical Research Council Unit, The Gambia

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of gametocytes 7 days after treatment
Secondary	Presence of gametocytes 56 days after treatment
Secondary	Asexual parasitaemia 14 days after treatment