A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants
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A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants. / Kobbe, Robin; Kreuzberg, Christina; Adjei, Samuel; Thompson, Benedicta; Langefeld, Iris; Thompson, Peter Apia; Abruquah, Harry Hoffman; Kreuels, Benno; Ayim, Matilda; Busch, Wibke; Marks, Florian; Amoah, Kwado; Opoku, Ernest; Meyer, Christian G; Adjei, Ohene; May, Jürgen.
In: CLIN INFECT DIS, Vol. 45, No. 1, 01.07.2007, p. 16-25.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants
AU - Kobbe, Robin
AU - Kreuzberg, Christina
AU - Adjei, Samuel
AU - Thompson, Benedicta
AU - Langefeld, Iris
AU - Thompson, Peter Apia
AU - Abruquah, Harry Hoffman
AU - Kreuels, Benno
AU - Ayim, Matilda
AU - Busch, Wibke
AU - Marks, Florian
AU - Amoah, Kwado
AU - Opoku, Ernest
AU - Meyer, Christian G
AU - Adjei, Ohene
AU - May, Jürgen
PY - 2007/7/1
Y1 - 2007/7/1
N2 - BACKGROUND: Intermittent preventive antimalarial treatment in infants (IPTi) with sulfadoxine-pyrimethamine reduces falciparum malaria and anemia but has not been evaluated in areas with intense perennial malaria transmission. It is unknown whether an additional treatment in the second year of life prolongs protection.METHODS: A randomized, double-blinded, placebo-controlled trial with administration of sulfadoxine-pyrimethamine therapy at 3, 9, and 15 months of age was conducted with 1070 children in an area in Ghana where malaria is holoendemic. Participants were monitored for 21 months after recruitment through active follow-up visits and passive case detection. The primary end point was malaria incidence, and additional outcome measures were anemia, outpatient visits, hospital admissions, and mortality. Stratified analyses for 6-month periods after each treatment were performed.RESULTS: Protective efficacy against malaria episodes was 20% (95% confidence interval [CI], 11%-29%). The frequency of malaria episodes was reduced after the first 2 sulfadoxine-pyrimethamine applications (protective efficacy, 23% [95% CI, 6%-36%] after the first dose and 17% [95% CI, 1%-30%] after the second dose). After the third treatment at month 15, however, no protection was achieved. Protection against the first or single anemia episode was only significant after the first IPTi dose (protective efficacy, 30%; 95% CI, 5%-49%). The number of anemia episodes increased after the last IPTi dose (protective efficacy, -24%; 95% CI, -50% to -2%).CONCLUSION: In an area of intense perennial malaria transmission, sulfadoxine-pyrimethamine-based IPTi conferred considerably lower protection than reported in areas where the disease is moderately or seasonally endemic. Protective efficacy is age-dependent, and extension of IPTi into the second year of life does not provide any benefit.
AB - BACKGROUND: Intermittent preventive antimalarial treatment in infants (IPTi) with sulfadoxine-pyrimethamine reduces falciparum malaria and anemia but has not been evaluated in areas with intense perennial malaria transmission. It is unknown whether an additional treatment in the second year of life prolongs protection.METHODS: A randomized, double-blinded, placebo-controlled trial with administration of sulfadoxine-pyrimethamine therapy at 3, 9, and 15 months of age was conducted with 1070 children in an area in Ghana where malaria is holoendemic. Participants were monitored for 21 months after recruitment through active follow-up visits and passive case detection. The primary end point was malaria incidence, and additional outcome measures were anemia, outpatient visits, hospital admissions, and mortality. Stratified analyses for 6-month periods after each treatment were performed.RESULTS: Protective efficacy against malaria episodes was 20% (95% confidence interval [CI], 11%-29%). The frequency of malaria episodes was reduced after the first 2 sulfadoxine-pyrimethamine applications (protective efficacy, 23% [95% CI, 6%-36%] after the first dose and 17% [95% CI, 1%-30%] after the second dose). After the third treatment at month 15, however, no protection was achieved. Protection against the first or single anemia episode was only significant after the first IPTi dose (protective efficacy, 30%; 95% CI, 5%-49%). The number of anemia episodes increased after the last IPTi dose (protective efficacy, -24%; 95% CI, -50% to -2%).CONCLUSION: In an area of intense perennial malaria transmission, sulfadoxine-pyrimethamine-based IPTi conferred considerably lower protection than reported in areas where the disease is moderately or seasonally endemic. Protective efficacy is age-dependent, and extension of IPTi into the second year of life does not provide any benefit.
KW - Animals
KW - Antimalarials
KW - Double-Blind Method
KW - Drug Combinations
KW - Female
KW - Ghana
KW - Humans
KW - Infant
KW - Malaria, Falciparum
KW - Male
KW - Placebos
KW - Plasmodium falciparum
KW - Prevalence
KW - Pyrimethamine
KW - Sulfadoxine
KW - Treatment Outcome
U2 - 10.1086/518575
DO - 10.1086/518575
M3 - SCORING: Journal article
C2 - 17554695
VL - 45
SP - 16
EP - 25
JO - CLIN INFECT DIS
JF - CLIN INFECT DIS
SN - 1058-4838
IS - 1
ER -
