Mass-Drug Administration to Reduce Malaria Transmission (MDATRANS)

This study has been completed.
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
London School of Hygiene and Tropical Medicine
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00509015
First received: July 30, 2007
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

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..


Condition Intervention
Malaria, Falciparum
Drug: Sulphadoxine-pyrimethamine (day 1: 500mg S&25mg P/20 kg)
Drug: Artesunate (day 1,2,3: 4 mg/kg)
Drug: Primaquine-base (day 3: 0.75 mg/kg)
Drug: placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • malaria morbidity by active and passive case detection. [ Time Frame: during the entire study period ] [ Designated as safety issue: Yes ]
  • asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA [ Time Frame: monthly during the entire study period ]
  • gametocyte prevalence and density by QT-NASBA and microscopy [ Time Frame: monthly during the entire study period ]
  • transmission intensity quantified by entomologic inoculation rate [ Time Frame: continuously during the study period ]
  • human infectious reservoir [ Time Frame: prior to the intervention and several months after the intervention ]

Secondary Outcome Measures:
  • asexual parasite and gametocyte density by microscopy and molecular QT-NASBA [ Time Frame: monthly during the study period ]
  • human immune responses to malaria antigens [ Time Frame: prior to the intervention and several months after the intervention ]
  • the prevalence of drug resistant parasite strains [ Time Frame: prior to the intervention and several months after the intervention ]
  • Possible side effects of intervention with primaquine, notably hemolysis [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6000
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sulphadoxine-pyrimethemine (day 1) artesunate (day 1-3) primaquine (day 3)
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
Placebo Comparator: 2
Placebo: lactose tablets (Albochin)
Drug: placebo tablets
3 days of lactose tablets (160mg) albochin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • permanent resident of the research area
  • age >1 years

Exclusion Criteria:

  • severe anemia
  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00509015

Locations
Tanzania
Kilimanjaro Christian Medical Centre
Moshi, Tanzania
Sponsors and Collaborators
Radboud University
Kilimanjaro Christian Medical Centre, Tanzania
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Seif Shekalaghe, MPH MD Kilimanjaro Christian Medical Centre
Study Chair: Robert Sauerwein, Prof MD PhD Radboud University
Study Director: Frank Mosha, PhD Kilimanjaro Christian Medical Centre
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seif Shekalaghe, Kilimanjaro Christian Medical Centre
ClinicalTrials.gov Identifier: NCT00509015     History of Changes
Other Study ID Numbers: APRIORI1/01
Study First Received: July 30, 2007
Last Updated: August 12, 2008
Health Authority: Tanzania: Food & Drug Administration

Keywords provided by Radboud University:
antimalarials
malaria transmission
mass drug administration
artemisinin-based combination therapy
primaquine
gametocytes
QT-NASBA

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Primaquine
Pyrimethamine
Sulfadoxine
Artesunate
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on August 27, 2014