Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission
Sponsor
Tropical Medicine Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00646126
Collaborator
London School of Hygiene and Tropical Medicine (Other), International Atomic Energy Agency (Other)
1
2
Study Details
Study Description
Brief Summary
The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Validation of the Use of Istope-Based Molecular Techniques for Malaria Control
Study Start Date
:
Aug 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 1:Active comparator sulfadoxine-pyrimethamine plus artesunate |
Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
Standard three day regimen
|
| Placebo Comparator: 2 2:placebo comparator |
Drug: placebo tablet similar to active drug in shape and size
Dosage similar to active drug(standard three days regimen)
|
Outcome Measures
Primary Outcome Measures
- Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages [October to December 2006]
Secondary Outcome Measures
- 1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes []
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- All residents of the 8 villages
Exclusion Criteria:
-
Pregnancy
-
History of allergy to sulfa drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tropical Medicine Research Institute | Khartoum | Sudan | 11111 |
Sponsors and Collaborators
- Tropical Medicine Research Institute
- London School of Hygiene and Tropical Medicine
- International Atomic Energy Agency
Investigators
- Principal Investigator: Badria B El Sayed, PhD,MSc,BSc, Tropical Medicine Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00646126
Other Study ID Numbers:
- SUD 6/025
First Posted:
Mar 28, 2008
Last Update Posted:
Mar 28, 2008
Last Verified:
Aug 1, 2005