ArticleContemporary clinical trials2025
Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial.
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Screening and tuberculosis preventive treatment among household contacts of drug-resistant tuberculosis patients: a scoping review.BMC infectious diseases · 2026Article
- Real-time electronic drug monitoring: experiences from a multinational phase 3 clinical trial to prevent multidrug-resistant TB.IJTLD open · 2026Article
- Article
- Operational considerations of select new treatment recommendations for drug-susceptible and drug-resistant tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2025Review
- Multidrug-resistant tuberculosis in children: A practical update on epidemiology, diagnosis, treatment and prevention.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Updated considerations in the diagnosis and management of tuberculosis infection and disease: integrating the latest evidence-based strategies.Expert review of anti-infective therapy · 2023Review
- Tuberculosis Diagnosis and Preventive Monotherapy Among Children and Adolescents Exposed to Rifampicin-Resistant Tuberculosis in the Household.Open forum infectious diseases · 2023Article
- The cascade of care for household contacts of people with drug-resistant TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Article
- Challenges and the Way forward in Diagnosis and Treatment of Tuberculosis Infection.Tropical medicine and infectious disease · 2023Review
- Treatment of Rifampicin-Resistant Tuberculosis Disease and Infection in Children: Key Updates, Challenges and Opportunities.Pathogens (Basel, Switzerland) · 2022Review
- Article
- New opportunities in tuberculosis prevention: implications for people living with HIV.Journal of the International AIDS Society · 2020Article
- Global burden of latent multidrug-resistant tuberculosis: trends and estimates based on mathematical modelling.The Lancet. Infectious diseases · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
introductionData to guide tuberculosis (TB) preventive treatment (TPT) of close contacts of people with multidrug-resistant tuberculosis (MDR-TB) are limited. While levofloxacin-based TPT has been shown safe and efficacious, alternatives are needed for those exposed to fluoroquinolone-resistant Mycobacterium tuberculosis (M. tb). The PHOENIx trial evaluates whether using a novel nitroimidazole, delamanid, in high-risk household contacts (HHCs) of patients with MDR-TB reduces their risk of developing active TB. METHODS/
designPHOENIx is a phase 3, open-label, multicenter clinical trial with a cluster-randomized superiority design (households form the clusters). The study objectives are to compare efficacy and safety of 26 weeks of delamanid versus isoniazid for preventing confirmed or probable TB during 96 weeks of follow-up among HHCs of adults with pulmonary MDR-TB. HHCs are defined as young children <5 years, people living with HIV or non-HIV immunosuppression, or people with evidence of M. tb infection. The study was originally designed to enroll 3452 HHCs to provide 90 % power to detect a 50 % reduction in the cumulative proportion of HHCs developing confirmed or probable TB during 96 weeks of follow-up from 5 % in the isoniazid arm to 2.5 % in the delamanid arm. The design included a sample size re-evaluation to address uncertainty in study design assumptions. DISCUSSION: Preventing MDR-TB is a global priority. Alternatives to levofloxacin-based TPT are needed since fluoroquinolone resistance is growing. PHOENIx, a phase 3 trial evaluating delamanid, is poised to inform WHO guidelines.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.