Mass-Drug Administration to Reduce Malaria Transmission

NCT00509015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2008-08-13

No results posted yet for this study

Summary

In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Sulphadoxine-pyrimethamine (day 1: 500mg S&25mg P/20 kg)

500mg S\&25mg P/20 kg, 1 day, single dose

DRUG

Artesunate (day 1,2,3: 4 mg/kg)

4 mg/kg, daily single dose over three days

DRUG

Primaquine-base (day 3: 0.75 mg/kg)

single dose at 0.75 mg/kg on day 3

DRUG

placebo tablets

3 days of lactose tablets (160mg) albochin

Sponsors & Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Seif Shekalaghe, MPH MD · Kilimanjaro Christian Medical Centre

  • Robert Sauerwein, Prof MD PhD · Radboud University Medical Center

  • Frank Mosha, PhD · Kilimanjaro Christian Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509015 on ClinicalTrials.gov