Mass-Drug Administration to Reduce Malaria Transmission (MDATRANS)
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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 |
- 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 ]
- 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 |
Inclusion Criteria:
- permanent resident of the research area
- age >1 years
Exclusion Criteria:
- severe anemia
- pregnancy
Contacts and Locations| Tanzania | |
| Kilimanjaro Christian Medical Centre | |
| Moshi, Tanzania | |
| Principal Investigator: | Seif Shekalaghe, MPH MD | Kilimanjaro Christian Medical Centre |
| Study Chair: | Robert Sauerwein, Prof MD PhD | Radboud University Medical Centre |
| 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 Sulfadoxine-pyrimethamine 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 May 23, 2013