Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
| Condition | Intervention |
|---|---|
|
Malaria |
Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management |
- incidence rate of clinical malaria [ Designated as safety issue: No ]
- in vivo adequate clinical and parasitological response of P. falciparum to SP [ Designated as safety issue: No ]
| Enrollment: | 262 |
| Study Start Date: | July 2002 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Control group
|
|
|
Experimental: 2
Test group
|
Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
|
Eligibility| Ages Eligible for Study: | 6 Months to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 6 months to 10 years
- Agree to seek initial medical care for all medical illness in the study clinic during the study period
- Written informed consent by a parent or legal garden,
- No plan to travel for a long time during the study period.
Exclusion Criteria:
- History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
- Chronic illness or symptomatic malaria at the time of enrollment
Contacts and Locations| Mali | |
| Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako | |
| Bamako, Mali | |
| Study Director: | Ogobara Doumbo, MD | University of Bamako |
| Principal Investigator: | Alassane Dicko, MD | University of Bamako |
More Information
No publications provided by University of Bamako
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Alassane Dicko, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako |
| ClinicalTrials.gov Identifier: | NCT00623155 History of Changes |
| Other Study ID Numbers: | A10828 |
| Study First Received: | February 14, 2008 |
| Last Updated: | February 22, 2008 |
| Health Authority: | Mali: Ministry of Health |
Keywords provided by University of Bamako:
|
malaria intermittent preventive treatment season children |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Pyrimethamine Sulfadoxine 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 |
ClinicalTrials.gov processed this record on May 16, 2013