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Mass-Drug Administration to Reduce Malaria Transmission (MDATRANS)

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ClinicalTrials.gov Identifier: NCT00509015
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : August 13, 2008
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
London School of Hygiene and Tropical Medicine
Information provided by:
Radboud University

Brief 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..

Condition or disease Intervention/treatment Phase
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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe anemia
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509015


Locations
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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
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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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seif Shekalaghe, Kilimanjaro Christian Medical Centre
ClinicalTrials.gov Identifier: NCT00509015     History of Changes
Other Study ID Numbers: APRIORI1/01
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: August 2008
Keywords provided by Radboud University:
antimalarials
malaria transmission
mass drug administration
artemisinin-based combination therapy
primaquine
gametocytes
QT-NASBA
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Primaquine
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents