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Treatment guided by rapid diagnostic tests for malaria in Tanzanian children: safety and alternative bacterial diagnoses

George Mtove1, Ilse CE Hendriksen2, Ben Amos3, Hedwiga Mrema3, Victor Mandia3, Alphaxard Manjurano4, Florida Muro4, Alma Sykes3, Helena Hildenwall5, Christopher JM Whitty6 and Hugh Reyburn67*

Author Affiliations

1 National Institute for Medical Research, Amani Centre, Muheza, Tanga, Tanzania

2 Mahidol-Oxford Research Unit, Mahidol University, Bangkok 10500, Thailand

3 Teule Hospital, Muheza, Tanzania

4 Kilimanjaro Christian Medical Centre, Moshi, Tanzania

5 Division of Global Health, Karolinska Institute, Nobels V13, 17177 Stockholm, Sweden

6 London School of Hygiene and Tropical Medicine, Keppel St, London WCIE7HT, UK

7 Joint Malaria Programme, PO. Box 2228, KCMC, Moshi, Tanzania

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Malaria Journal 2011, 10:290  doi:10.1186/1475-2875-10-290

Published: 6 October 2011

Abstract

Background

WHO guidelines for the treatment of young children with suspected malaria have recently changed from presumptive treatment to anti-malarial treatment guided by a blood slide or malaria rapid diagnostic test (RDT). However, there is limited evidence of the safety of this policy in routine outpatient settings in Africa.

Methods

Children 3-59 months of age with a non-severe febrile illness and no obvious cause were enrolled over a period of one year in a malaria endemic area of Tanzania. Treatment was determined by the results of a clinical examination and RDT result, and blood culture and serum lactate were also collected. RDT-negative children were followed up over 14 days.

Results

Over the course of one year, 965 children were enrolled; 158 (16.4%) were RDT-positive and treated with artemether-lumefantrine and 807 (83.4%) were RDT-negative and treated with non-anti-malarial medicines. Compared with RDT-positives, RDT-negative children were on average younger with a lower axillary temperature and more likely to have a history of cough or difficulty in breathing. Six (0.6%) children became RDT-positive after enrolment, all of whom were PCR-negative for Plasmodium falciparum DNA at enrolment. In addition, 12 (1.2%) children were admitted to hospital, one with possible malaria, none of whom died. A bacterial pathogen was identified in 9/965 (0.9%) children, eight of whom were RDT-negative and one was RDT-positive, but slide-negative. Excluding three children with Salmonella typhi, all of the children with bacteraemia were ≤12 months of age. Compared to double-read research slide results RDTs had a sensitivity of 97.8% (95%CI 96.9-98.7) and specificity of 96.3% (95%CI 96.3-98.4).

Conclusions

Use of RDTs to direct the use of anti-malarial drugs in young children did not result in any missed diagnoses of malaria although new infections soon after a consultation with a negative RDT result may undermine confidence in results. Invasive bacterial disease is uncommon in children with non-severe illness and most cases occurred in infants with a current fever.