NCT00206739|CompletedPhase 4DMC
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Sponsor study identifier
Secondary identifiers
interventional
1,070
1 country
1
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2005
Actual (reported)Study Completion
September 2005
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 2005
Actual (reported)September 2005
Actual (reported)September 13, 2005
Actual (reported)September 21, 2005
Actual (reported)• 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
• 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
• Antibody responses against parasite antigens
• Multiplicity of P. falciparum infections
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kumasi Centre for Collaborative Research in Tropical Medicine
Kumasi, Ashanti Region, Ghana
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.
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.
Ohene Adjei, Prof. Dr.
Kumasi Centre for Collaborative Research in Tropical Medicine
Jürgen May, PD Dr.
Bernhard Nocht Institute for Tropical Medicine Hamburg, Infection Epidemiology
1,070 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
September 2005
Actual (reported)Study Completion
September 2005
Actual (reported)Last Updated
March 30, 2010
Record last verified: 2005-09
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