Challenges of sharing individual participant data for secondary research on neglected tropical diseases: the experience of Drugs for Neglected Diseases initiative and a call for action.

Introduction: The Drugs for Neglected Diseases initiative (DNDi) is committed to maximising the scientific value of the individual participant data (IPD) it has collected during its 20 years of activity and the IPD it will collect in the future, while safeguarding research participants' privacy and their right to know how their data will be processed.

Objective: The objective of this article is to share what DNDi has learnt while working on its commitment to data sharing. It also aims to advance the debate about best practice in the research community to avoid 'IPD sharing paralysis', with a focus on multistakeholder projects involving patients and researchers based in countries with various levels of data privacy regulations and measures.

Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial.

Background: Eumycetoma is an implantation mycosis characterised by a large subcutaneous mass in the extremities commonly caused by the fungus Madurella mycetomatis. Despite the long duration of treatment, commonly a minimum of 12 months, treatment failure is frequent and can lead to amputation. We aimed to compare the efficacy of two doses of fosravuconazole, a synthetic antifungal designed for use in onychomycosis and repurposed for mycetoma, with standard-of-care itraconazole, both in combination with surgery.

Safety and efficacy of paromomycin/miltefosine/liposomal amphotericin B combinations for the treatment of post-kala-azar dermal leishmaniasis in Sudan: A phase II, open label, randomized, parallel arm study.

Background: Treatment for post-kala-azar dermal leishmaniasis (PKDL) in Sudan is currently recommended only for patients with persistent or severe disease, mainly because of the limitations of current therapies, namely toxicity and long hospitalization. We assessed the safety and efficacy of miltefosine combined with paromomycin and liposomal amphotericin B (LAmB) for the treatment of PKDL in Sudan.

Methodology/principal Findings: An open-label, phase II, randomized, parallel-arm, non-comparative trial was conducted in patients with persistent (stable or progressive disease for ≥ 6 months) or grade 3 PKDL, aged 6 to ≤ 60 years in Sudan.

Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa: A Randomized, Controlled, Multicountry Trial.

Background: This study aimed to determine whether paromomycin plus miltefosine (PM/MF) is noninferior to sodium stibogluconate plus paromomycin (SSG/PM) for treatment of primary visceral leishmaniasis in eastern Africa.

Methods: An open-label, phase 3, randomized, controlled trial was conducted in adult and pediatric patients at 7 sites in eastern Africa. Patients were randomly assigned to either 20 mg/kg paromomycin plus allometric dose of miltefosine (14 days), or 20 mg/kg sodium stibogluconate plus 15 mg/kg paromomycin (17 days).

Association between traumatic brain injury (TBI) patterns and mortality: a retrospective case-control study.

: Low and medium income countries (LMICs) such as Kenya experience nearly three times more cases of traumatic brain injury (TBI) compared to high income countries (HICs). This is primarily exacerbated by weak health systems especially at the pre-hospital care level. Generating local empirical evidence on TBI patterns and its influence on patient mortality outcomes is fundamental in informing the design of trauma-specific emergency medical service (EMS) interventions at the pre-hospital care level.