Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana

Abstract

Objective To test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis. Design Randomised, controlled, open label clinical trial. Setting Four clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria ("microscopy setting") and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms ("clinical setting"). Participants Patients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients. Main outcome measures The primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years. Results Of the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm. Conclusion Where microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.

Factoring Quality Laboratory Diagnosis into the Malaria Control Agenda for Sub-Saharan Africa

“…For laboratory tests to have a significant impact on malaria control and elimination, a paradigm shift is needed in patient care. The practice of treating patients for malaria when laboratory tests are negative and the risk of severe malaria is low 8,12 should be discouraged. Professional associations (including those associations for nurses and clinical officers) in endemic countries have a significant role to play in communicating changes in clinical management of malaria to their members.…”

“…When good-quality malaria laboratory diagnosis is available and assuming test results are followed, prescribing of antimalarials to patients with nonmalaria fever can be minimized. 12,[31][32][33] Although resources are currently unavailable to fully equip health centers with a wide array of laboratory tests, periodic systematic evaluation of prevalent non-malarial febrile diseases could be conducted to determine the most critical laboratory tests and suggest what anti-infective agents should be recommended for treatment. Such streamlining would represent a more efficient use of limited resources and could be a portal for integrated clinical and laboratory services for multiple diseases.…”

“…5,6 A consequence of the prolonged neglect of laboratories in malaria case management is that, even when quality laboratory services are available, clinicians too frequently ignore negative results. [7][8][9][10][11][12] The reduction in clinical malaria in several countries [13][14][15][16] and the use of expensive artemisinin-based combination therapeutic (ACT) antimalarial drugs call for case management practices that emphasize parasitologic confirmation, because continued use of ACTs in non-malaria cases represents a waste of resources and eventually, is unsustainable. Indiscriminate use of ACTs could create sufficient drug pressure that hastens development of resistant parasites, a situation that has begun to develop in Southeast Asia.…”

"Test and treat" or presumptive treatment for malaria in high transmission situations? A reflection on the latest WHO guidelines

“…Some studies show that use of RDTs increases antibiotic prescribing in malaria-negative patients [20,21] (Table 2). If the disease is a common cold, antibiotics should generally be avoided.…”

Health Care Worker’s Experience on Rapid Diagnostic Test (Rdt) for Malaria and Their Views on Community Acceptability of Rdt in Rubavu District, Rwanda: Qualitative Study

“…In order to have effective case management of malaria, clinical assessment and laboratory confirmation through light microscopy or RDTs should be addressed prior to treatment with an effective antimalarial [7][8][9][10]. There is evidence that using artemisinin combination therapies (ACTs) at the community level using trained community health workers is feasible, effective, and saves lives [11,12].…”