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Simple clinical decision model for predicting leptospirosis: a secondary analysis of a randomized controlled trial

Gupta N, Kumar TP, Van Den Broucke S, Vlieghe E, Bottieau E

Transactions of the Royal Society of Tropical Medicine and Hygiene, 2026

190 participants

Abstract

BACKGROUND: Leptospirosis is a major cause of febrile illness in tropical regions, but early diagnosis is challenging due to overlapping clinical features and delayed serological confirmation. We developed a simple bedside decision model using readily available clinical variables.

METHODS: This secondary analysis used archived data from a randomized controlled trial of adults with undifferentiated febrile illness (October 2020-February 2021) of 5-15 days' duration. Independent predictors of IgM-ELISA positive leptospirosis were identified using multivariable logistic regression. A simplified score assigning one point per predictor was derived. Discrimination was assessed using ROC analysis, and post-test probabilities were modelled for clinical combinations and simulated rapid diagnostic testing.

RESULTS: Among 190 patients, 48 (25.3%) were serologically positive for leptospirosis. Conjunctival suffusion, icterus and acute kidney injury were independent predictors. The score (0-3) showed good discrimination (AUC 0.801), with sensitivity 68.8% and specificity 82.4% at ≥2. An exploratory proteinuria-based model demonstrated moderate discrimination (AUC 0.741). Probability increased from 25% at baseline to 91% when all three predictors were present and to 97%-99% when combined with a positive rapid test.

CONCLUSIONS: A simple bedside score substantially increases the probability of diagnosing leptospirosis in patients with undifferentiated febrile illness of 5-15 days'…

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 190 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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