The chagas disease study landscape: Preliminary analysis of a systematic review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform

Significant limitations still exist in our understanding of Chagas disease including its pathologies, factors relating to progression, biomarkers to indicate parasite clearance or cure and optimal treatment regimens for all patient populations. Existing data collected in past trials could be standardised and pooled to address research priorities and knowledge gaps. We conducted a systematic literature review to understand the scope of Chagas clinical studies and assess the technical feasibility of establishing an individual participant-level data (IPD) platform. Following PRISMA guidance, a review of Chagas clinical drug trials and observational investigations conducted between 1998 and 2017 was performed across 4 databases and 2 clinical trial registries. All clinical studies enrolling patients with a confirmed Chagas diagnosis and at least one follow-up measurement was included. Descriptive and thematic analysis of study characteristics has been conducted and R statistical computing software for analysis where possible. A total of 10,319 articles were screened and 43 trypanocidal treatment trials have been identified. The 43 trials cover 12 different countries, 6 interventions, 67 study arms representing 25 different treatment regimens. A total of 9,803 Chagas patients were treated and followed-up, with 37 testing Benznidazole and 5 testing Nifurtimox, accounting for 74% of all patients. 38 out of 43 studies reported parasitaemia-related outcome measures assessed post-baseline. Serology and PCR were the primary methods for outcome measurement in 6,101 and 5,284 patients, respectively. Adverse events were reported in 33 studies representing 9,114 patients. Duration of follow-up ranged from 56 days to 20 years. The clinical need, potential utilisation and quantity of data identified from preliminary analysis of this systematic review suggests development of a Chagas IPD data platform for clinical research would enable optimisation of existing data and more in-depth analyses to strengthen evidence for treatment and diagnosis of Chagas disease and inform prospective data collection.