The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00137553|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : March 16, 2010
|First Submitted Date ICMJE||August 28, 2005|
|First Posted Date ICMJE||August 30, 2005|
|Last Update Posted Date||March 16, 2010|
|Study Start Date ICMJE||May 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00137553 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children|
|Official Title ICMJE||The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau|
Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for the treatment of malaria will, if getting malaria during follow-up, be re-treated with sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria Programme.
To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick blood sample will be collected for a malaria test.
Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre.
The Bandim Health Project studies the efficacy of different treatment regimens for malaria in children. If the included children during follow-up get malaria again they are, according to the recommendations of the National Malaria Programme, treated with sulfadoxine-pyrimethamine (SP).
In 1995 - 1996 the efficacy of this re-treatment regimen was evaluated in the same area.
To evaluate if treatment with SP is still efficient we want to follow children included in a study comparing treatment with chloroquine and amodiaquine having recrudescent malaria for 35 days following the re-treatment with SP.
Children with reappearing parasitaemia will be treated with SP. If accepting to participate in this study the children will be visited once a week and a capillary blood sample will be drawn. The blood sample taken on the day of reappearing parasitaemia in the chloroquine/amodiaquine study will be used as the day 0 blood sample in the SP-study.
If the child gets malaria during the follow-up he will be treated according to the guidelines of the Bandim Health Centre. All treatment during follow-up will be free.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Malaria, Falciparum|
|Intervention ICMJE||Drug: Sulfadoxine-pyrimethamine (Fansidar)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||March 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 15 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Guinea-Bissau|
|Removed Location Countries|
|NCT Number ICMJE||NCT00137553|
|Other Study ID Numbers ICMJE||PSB-2001-Fansidar|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Bandim Health Project|
|Collaborators ICMJE||Not Provided|
|PRS Account||Bandim Health Project|
|Verification Date||March 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP