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1 July 2007

Volume 45, Number 1
Clinical Infectious Diseases 2007;45:16–25
© 2007 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2007/4501-0005$15.00
DOI: 10.1086/518575
MAJOR ARTICLE

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

Robin Kobbe,1

Christina Kreuzberg,1

Samuel Adjei,1,3

Benedicta Thompson,3

Iris Langefeld,1

Peter Apia Thompson,4

Harry Hoffman Abruquah,4

Benno Kreuels,1

Matilda Ayim,4

Wibke Busch,1

Florian Marks,1,5

Kwado Amoah,4

Ernest Opoku,4

Christian G. Meyer,2

Ohene Adjei,4 and

Jürgen May1

1Infectious Disease Epidemiology Group and 2Department of Molecular Medicine, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; 3Ministry of Health/Ghana Health Service, District Health Directorate, Agona, Ashanti Region, and 4Kumasi Centre for Collaborative Research in Tropical Medicine, Kumasi, Ghana; and 5International Vaccine Institute, Seoul, South Korea

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.

Received 15 December 2006; accepted 15 February 2007; electronically published 29 May 2007.

  • (See the editorial commentary by Greenwood on pages 26–8)

Reprints or correspondence: Dr. Jürgen May, Infectious Disease Epidemiology Group, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, D‐20359 Hamburg, Germany ().

Cited by

R. D. Gosling, I. Carneiro, D. Chandramohan. (2009) Intermittent preventive treatment of malaria in infants: how does it work and where will it work?. Tropical Medicine & International Health
Online publication date: 1-Jul-2009.
CrossRef
Kalifa A Bojang. (2009) Novel therapies for the prevention of malaria. Expert Opinion on Investigational Drugs 17:12, 1839-1847
Online publication date: 1-Jan-2009.
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N. SCHREIBER, A. KHATTAB, M. PETTER, F. MARKS, S. ADJEI, R. KOBBE, J. MAY, M.-Q. KLINKERT. (2008) Expression of Plasmodium falciparum 3D7 STEVOR proteins for evaluation of antibody responses following malaria infections in naïve infants. Parasitology 135:02,
Online publication date: 1-Mar-2008.
CrossRef
Benno Kreuels, Robin Kobbe, Samuel Adjei, Christina Kreuzberg, Claudia von Reden, Kathrin Bäter, Stefan Klug, Wibke Busch, Ohene Adjei, and Jürgen May. (2008) Spatial Variation of Malaria Incidence in Young Children from a Geographically Homogeneous Area with High Endemicity. The Journal of Infectious Diseases 197:1, 85-93
Online publication date: 1-Jan-2008.
Abstract-Full Text-PDF Version (252 kB)
Martin P Grobusch, Andrea Egan, Roly D Gosling, Robert D Newman. (2008) Intermittent preventive therapy for malaria: progress and future directions. Current Opinion in Infectious Diseases 20:6, 613-620
Online publication date: 1-Jan-2008.
CrossRef
Brian Greenwood. (2007) Editorial Commentary: Intermittent Preventive Antimalarial Treatment in Infants. Clinical Infectious Diseases 45:1, 26-28
Online publication date: 1-Jul-2007.
Citation-Full Text-PDF Version (183 kB)
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