Reducing the Effects of Malaria in Children by Administering Repeated Preventive Doses
NCT ID: NCT00167843
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1189 participants
INTERVENTIONAL
2002-12-31
2007-03-31
Brief Summary
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Detailed Description
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Malaria control measures have been assessed for their potential to reduce intensity of infection in order to decrease the risk of malaria. It has been shown that malaria prevention using drugs is potentially capable to reduce malaria morbidity, school absenteeism, and all-cause mortality. However, prevention using drugs in the first years of life can also result in the loss or delay of acquired resistance which can lead to a rebound phenomenon (i.e. an increased risk of severe malaria after the therapy ended). In a recent study on intermittent treatment with Fansidar® at 2, 3, and 9 months of age, the number of malaria cases during the first 12 months of life was significantly reduced and no rebound effect was observed. This study has demonstrated that the intermittent administration of Fansidar® is safe and has beneficial effects for the children. However, the effectiveness decreased some months after discontinuing the drug. The promising effect of the intermittent administration of fansidar shown in this study needs to be confirmed in areas of different endemicity such as Lambaréné, Gabon. It is assumed that a more extended intermittent application of Fansidar® than performed in the above example would likely result in a longer period of protection from malaria, and the extended intermittent administration of Fansidar should not lead to rebound effects resulting in a higher occurrence of malaria.
The framework of this study offers a unique opportunity to study characteristics of infectious disease of importance in the Lambaréné area and the development of resistance against microbes at the maternofetal (mother/foetus) interface. Comparable studies will simultaneously take place in two associated study sites (Kumasi and Tamale) with different malaria endemicity in Ghana, West Africa.
Comparison: Comparison of malaria attacks in children with and without intermittent Fansidar® treatment with drug administration at months 3 and 9 (alongside with routine vaccinations delivered through child vaccination programme) and an additional administration at month 15.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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sulfadoxine-pyrimethamine
Eligibility Criteria
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Inclusion Criteria
* Permanent residence in the study area
Exclusion Criteria
* Signs of severe hepatic or renal dysfunction not due to malaria
5 Months
ALL
Yes
Sponsors
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Medical Research Unit, Lambarene
UNKNOWN
Bundesministerium fuer Bildung und Forschung (BMBF)
UNKNOWN
Deutscher Akademischer Austausch Dienst
OTHER
German Research Foundation
OTHER
Bill and Melinda Gates Foundation
OTHER
Albert Schweitzer Hospital
OTHER
Principal Investigators
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Peter G Kremsner, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Schweitzer Hospital
Locations
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Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, Gabon
Countries
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References
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WHO. In WHO report: Fostering Development, Geneva, 1996
Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, N'Jie AB. Comparison of two strategies for control of malaria within a primary health care programme in the Gambia. Lancet. 1988 May 21;1(8595):1121-7. doi: 10.1016/s0140-6736(88)91949-6.
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.
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.
Bradley-Moore AM, Greenwood BM, Bradley AK, Bartlett A, Bidwell DE, Voller A, Kirkwood BR, Gilles HM. Malaria chemoprophylaxis with chloroquine in young Nigerian children. I. Its effect on mortality, morbidity and the prevalence of malaria. Ann Trop Med Parasitol. 1985 Dec;79(6):549-62. doi: 10.1080/00034983.1985.11811962.
Diagne N, Rogier C, Sokhna CS, Tall A, Fontenille D, Roussilhon C, Spiegel A, Trape JF. Increased susceptibility to malaria during the early postpartum period. N Engl J Med. 2000 Aug 31;343(9):598-603. doi: 10.1056/NEJM200008313430901.
Gabor JJ, Schwarz NG, Esen M, Kremsner PG, Grobusch MP. Dengue and chikungunya seroprevalence in Gabonese infants prior to major outbreaks in 2007 and 2010: A sero-epidemiological study. Travel Med Infect Dis. 2016 Jan-Feb;14(1):26-31. doi: 10.1016/j.tmaid.2016.01.005. Epub 2016 Jan 29.
Grobusch MP, Gabor JJ, Aponte JJ, Schwarz NG, Poetschke M, Doernemann J, Schuster K, Koester KB, Profanter K, Borchert LB, Kurth F, Pongratz P, Issifou S, Lell B, Kremsner PG. No rebound of morbidity following intermittent preventive sulfadoxine-pyrimethamine treatment of malaria in infants in Gabon. J Infect Dis. 2009 Dec 1;200(11):1658-61. doi: 10.1086/647990.
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.
Grobusch MP, Lell B, Schwarz NG, Gabor J, Dornemann J, Potschke M, Oyakhirome S, Kiessling GC, Necek M, Langin MU, Klein Klouwenberg P, Klopfer A, Naumann B, Altun H, Agnandji ST, Goesch J, Decker M, Salazar CL, Supan C, Kombila DU, Borchert L, Koster KB, Pongratz P, Adegnika AA, Glasenapp Iv, Issifou S, Kremsner PG. Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2007 Dec 1;196(11):1595-602. doi: 10.1086/522160. Epub 2007 Oct 25.
Related Links
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Homepage of IPTi consortium
Homepage of the Medical Research Unit of the Albert Schweitzer Hospital
Other Identifiers
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28574
Identifier Type: -
Identifier Source: org_study_id
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