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Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.
Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.
Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia.
We calculated a sample size of 110 patients in each group for a power of 95% assuming that the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16 according to (schellenberg et al )
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloroquine | No Intervention | Weekly CQ | |
| Sulfadoxine-pyrimethamine | No Intervention | Monthly SP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulfadoxine pyrimethamine | Drug | Monthly SP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Malaria episodes | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Malaria related admissions | 1 month | |
| Adverse drug effects | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Nakibuuka, MBChB | Department of Paediatrics and Child Health , Makerere University | Principal Investigator |
| Grace Ndeezi, M.Med | Department of Paediatrics and Child Health, Makerere University | Principal Investigator |
| Deborah Nakiboneka, M.Med | Department of Paediatrics and Child Health, Makerere University | Principal Investigator |
| Christopher Ndugwa, PhD | Department of paediatrics and Child Health, Makerere University | Principal Investigator |
| James Tumwine, PhD | Department of Paediatrics and Child Health, Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Hospital | Kampala | Central Region | 256 | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11377597 | Background | Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2. | |
| 12788572 | Background |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
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| Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0. |
| 16503464 | Background | Cisse B, Sokhna C, Boulanger D, Milet J, Ba el H, Richardson K, Hallett R, Sutherland C, Simondon K, Simondon F, Alexander N, Gaye O, Targett G, Lines J, Greenwood B, Trape JF. Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children: a randomised, placebo-controlled, double-blind trial. Lancet. 2006 Feb 25;367(9511):659-67. doi: 10.1016/S0140-6736(06)68264-0. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |