Study protocol summary
A plan to test whether rapid tests plus a decision algorithm can cut unnecessary antibiotics without leaving patients worse off
Summarising the article
Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial
Dr. Phyu Hnin Hlaing · Trials · 2020
Study protocol
This is a research plan published before any data was collected. The journal reviews the method up front so that what gets reported later can be checked against what was announced — so there are no results on this page, only the question, the method, and what the team intends to do.
The question
Acute fevers arriving at outpatient clinics in low- and middle-income countries are clinically indistinguishable between bacterial and viral causes. Without diagnostics, prescribing antibiotics just in case has become common practice, and that feeds drug resistance. Can a package of rapid tests, a clinical algorithm, and training and communication reduce unnecessary prescribing without worsening clinical outcomes?
How it will be done
A randomised controlled trial across nine clinical sites in six countries — Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda — enrolling a minimum of 21,876 patients in total, with a 12-month recruitment window chosen so that seasonal variation in fever is covered. A master protocol was adapted for each country's ethics submission, and the tests and algorithms were chosen against existing data on what causes acute fever in each country. A qualitative evaluation of what drives and deters uptake of the new diagnostics runs alongside. Registered at ClinicalTrials.gov as NCT04081051.
What the study will do
- There are two primary outcomes and they have to be read together: the proportion of patients with a favourable outcome on day 7 — defined precisely as alive, without fever, and with day-zero symptoms resolved — and the proportion of antibiotic prescriptions in each arm.
- The target is declared in advance: a reduction of at least 30% from baseline in unnecessary prescribing, not merely some reduction.
- Three secondary outcomes: the proportion of patients reporting adherence to their prescription by day 7, the proportion of health workers who followed the new algorithm, and the proportion of participants experiencing adverse events.
- The gap that makes the trial necessary is stated plainly. The authors note that prescription rates at these sites are already known, but patient outcomes are not, because patients are not routinely followed up.
- Each site is powered to stand on its own, with results later combined in an aggregate-data meta-analysis treating the site as the unit of analysis.
Why this plan matters
If the trial delivers what it is designed for, the result is not simply a verdict on rapid tests but evidence for policymakers that prescribing can be reduced without trading away patient safety — the worry that keeps many services from changing practice. Pairing a clinical-outcome measure with the prescribing measure from the outset is what makes that answer credible.
What to know before citing this
This is a protocol, not a result. The published document is version 1.4, dated 20 December 2019, and no findings existed at publication. The control arm receives routine care, which the authors state will not be altered during the trial, and they acknowledge routine procedures may carry risks of their own, such as inappropriate antibiotic use or a missed diagnosis, which will be monitored. The design answers primarily at site level, so pooled results across six countries should be read with their differing contexts in mind.
Cite this work
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Salami, O., Horgan, P., Moore, C. E., Giri, A., Sserwanga, A., Pathak, A., Basnyat, B., Kiemde, F., Smithuis, F., Kitutu, F., Phutke, G., Tinto, H., Hopkins, H., Kapisi, J., Swe, M. M. M., Taneja, N., Baiden, R., Dutta, S., Compaore, A., ... Olliaro, P. (2020). Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: Protocol for a randomized controlled trial. Trials, 21(1), Article 974. https://doi.org/10.1186/s13063-020-04897-9
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