Treatment guided by rapid diagnostic tests for malaria in Tanzanian children: safety and alternative bacterial diagnoses
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Published on: May 12, 2022
George Mtove1, Ilse Ce Hendriksen, Ben Amos
11National Institute for Medical Research, Amani Centre, Muheza, Tanga,Tanzania.
Insights
Using malaria rapid diagnostic tests (RDTs) to guide treatment in young children safely identified malaria cases, aligning with new WHO guidelines. This approach did not miss malaria diagnoses in routine African outpatient settings.
Area of Science:
- Pediatric Infectious Diseases
- Tropical Medicine
- Diagnostic Accuracy Studies
Background:
- Recent WHO guidelines recommend malaria treatment guided by diagnostic tests (blood slide or RDT) instead of presumptive treatment for young children.
- Limited evidence exists on the safety and effectiveness of this policy in routine African outpatient settings.
Purpose of the Study:
- To evaluate the safety and diagnostic accuracy of using malaria rapid diagnostic tests (RDTs) to guide anti-malarial treatment in young children with febrile illness in Tanzania.
- To assess the incidence of missed malaria diagnoses and co-existing bacterial infections.
Main Methods:
- A prospective study enrolled 965 children aged 3-59 months with non-severe febrile illness in a malaria-endemic area.
- Treatment decisions were based on clinical examination and RDT results. Blood cultures and serum lactate were collected. RDT-negative children were followed for 14 days.
Main Results:
- 16.4% of children tested RDT-positive and received anti-malarials; 83.4% were RDT-negative. Six children (0.6%) became RDT-positive post-enrollment. Twelve children (1.2%) were hospitalized, one with possible malaria; no deaths occurred.
- RDTs demonstrated high sensitivity (97.8%) and specificity (96.3%) compared to slide results. Invasive bacterial disease was uncommon (0.9%), primarily affecting infants.
Conclusions:
- RDT-guided malaria treatment in young children is safe and effectively identifies malaria cases, aligning with WHO policy.
- While new infections can occur, RDTs accurately diagnose malaria in routine settings. Invasive bacterial disease is rare in non-severe febrile illnesses.
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 enrollment, all of whom were PCR-negative for Plasmodium falciparum DNA at enrollment. 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.
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