Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 01KA0202 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Deutscher Akademischer Austausch Dienst | OTHER |
| The Volkswagen Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality
In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are evaluated: i) the level of protection from malaria attacks and episodes of anemia during the treatment period, ii) the level of protection from severe malaria during the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv) the decrease of overall morbidity and mortality, including the number of hospital admissions and visits of hospital outpatient departments v) the influence of the intervention on the development of drug resistances, vi) the impact of the intervention on the development of immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction due to chronic Plasmodium falciparum infection. Parts of the study are performed in collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon and the School of Medicine and Health Sciences, University of Development Studies, Tamale, Ghana
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| • Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life) | ||
| • Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects | ||
| • Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children |
| Measure | Description | Time Frame |
|---|---|---|
| • Rate and time points of hospitalizations with anemia, malaria or other diseases | ||
| • Rate and time points of severe anemia episodes | ||
| • Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ohene Adjei, Prof. Dr. | Kumasi Centre for Collaborative Research in Tropical Medicine | Principal Investigator |
| Jürgen May, PD Dr. | Bernhard Nocht Institute for Tropical Medicine Hamburg, Infection Epidemiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumasi Centre for Collaborative Research in Tropical Medicine | Kumasi | Ashanti Region | Ghana |
| 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. | |
| 9310602 | Background |
| Label | URL |
|---|---|
| Homepage of the Kumasi Centre for Collaborative Research (study site) | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008288 | Malaria |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013413 | Sulfadoxine |
| D011739 | Pyrimethamine |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| • Antibody responses against parasite antigens |
| • Multiplicity of P. falciparum infections |
| • Proportion of P. falciparum isolates with SP resistance |
| • Influence of host genetic variants on the rate of P. falciparum infections |
| Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3. |
| 12788572 | Background | 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. |
| 12354473 | Background | Verhoef H, West CE, Nzyuko SM, de Vogel S, van der Valk R, Wanga MA, Kuijsten A, Veenemans J, Kok FJ. Intermittent administration of iron and sulfadoxine-pyrimethamine to control anaemia in Kenyan children: a randomised controlled trial. Lancet. 2002 Sep 21;360(9337):908-14. doi: 10.1016/S0140-6736(02)11027-0. |
| 18828899 | Derived | May J, Adjei S, Busch W, Gabor JJ, Issifou S, Kobbe R, Kreuels B, Lell B, Schwarz NG, Adjei O, Kremsner PG, Grobusch MP. Therapeutic and prophylactic effect of intermittent preventive anti-malarial treatment in infants (IPTi) from Ghana and Gabon. Malar J. 2008 Oct 1;7:198. doi: 10.1186/1475-2875-7-198. |
| 18067679 | Derived | Kobbe R, Adjei S, Kreuzberg C, Kreuels B, Thompson B, Thompson PA, Marks F, Busch W, Tosun M, Schreiber N, Opoku E, Adjei O, Meyer CG, May J. Malaria incidence and efficacy of intermittent preventive treatment in infants (IPTi). Malar J. 2007 Dec 9;6:163. doi: 10.1186/1475-2875-6-163. |
| D000079426 |
| Vector Borne Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013424 |
| Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |