A Randomized Controlled Trial of Extended Intermittent Preventive Antimalarial Treatment in Infants

Abstract

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, Ϫ24%; 95% CI, Ϫ50% to Ϫ2%).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.

Modeling the Relationship between Precipitation and Malaria Incidence in Children from a Holoendemic Area in Ghana

“…[31][32][33][34] Other studies have used geographic information systems and satellite imagery to investigate environmental factors that potentially drive the dynamics of malaria vector populations [34][35][36] and other vector-borne and zoonotic diseases such as dengue fever or hantavirus. [37][38][39] It has been shown that the efficacy of control measures such as intermittent preventive treatment (IPT) can be strongly dependent on the present malaria incidence, [40][41][42] and it can be assumed that direct and contextual effects increase with malaria risk after an intervention. The results of the present study highlight that it is feasible in holoendemic areas to predict fluctuations in the malaria incidence with information that is easy to obtain.…”

Q Fever in Young Children, Ghana

“…genavense causes up to 12.8% of all nontuberculous mycobacteria infections in AIDS patients; these infections are clinically similar to those caused by the M. avium complex (1,6).…”

“…Plasma was obtained by venous puncture from 2-year-old children after they had participated in a malaria control study and had been clinically monitored for 21 months. Clinical, parasitologic, socioeconomic, and Global Positioning System information was recorded as described elsewhere (6,7). In addition, 158 healthy adult volunteers from the same area were included.…”

Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania

“…Intermittent preventive treatment for malaria in infants (IPTi) is a promising new intervention consisting of the administration of a treatment dose of sulfadoxine/pyrimethamine (SP) at the time of routine vaccinations in the first year of life. 3 A pooled analysis 4 of six randomised controlled trials (RCT) of IPTi using SP (IPTi-SP) [5][6][7][8][9][10] suggested that the intervention can reduce the incidence of clinical malaria in the first year of life by 30%. If such an effect can be achieved by delivering an available and affordable antimalarial treatment at the time of routine contacts with the health system, IPTi-SP may become a useful component of antimalarial strategies in some settings.…”