Showing 1–20 of 20 documents
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Manjula Singh, Sindhu Joshi, Vikram Vohra, Rohit Sarin, Suchit Vasant Kamble, et al.
…ection, and immunogenicity. **DESIGN:** Phase 3 randomised clinical trial (PreVenTB trial). **SETTING:** 18 sites across six states of India. **PARTICIPANTS:** 12 717 healthy household contacts (aged ≥6 years) of patients with a smear positive TB test. **INTERVE…
Sara Domínguez-Rodríguez, David Lora, Alfredo Tagarro, Cinta Moraleda, Álvaro Ballesteros, et al.
**BACKGROUND:** The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized wi…
Kate Rich, Ronelle Burger, Andrew Boulle, Deanne Goldberg, Noxolo Gqada, et al.
…B Check. **DESIGN:** The study was a randomised controlled trial with a parallel design. **SETTING:** This study assessed mHealth support to boost TB testing in high-burden Cape Town clinics. **INTERVENTION:** Patients aged 18 or above with a valid mobile phone number that had…
Nusrat Shafiq, Ashok Kumar, Vikram Vohra, Gopal Krishan Khuller, Manjula Singh, et al.
…multicentric, investigator-initiated, randomized controlled trial designed to assess the non-inferiority of a 16 week clofazimine-based regimen compared with the standard 24 week regimen for drug-susceptible pulmonary TB (Clinical Trials Registry of India no. CTRI/2019/03/018102)…
Pichanon Mingchay, Kamon Kawkitinarong, Pattama Torvorapanit, Pirapon June Ohata, Gompol Suwanpimolkul
… for presumed PTB. **METHODS:** In a randomized controlled trial at King Chulalongkorn Memorial Hospital, Thailand, 204 adults with presumed PTB and negative Xpert MTB/RIF Ultra results or inadequate sputum production were enrolled between July and October 2024. Participants wer…
Nazir Ismail, Harry Moultrie, Judith Mwansa-Kambafwile, Andrew Copas, Alane Izu, et al.
…his pragmatic, open-label, individual randomised controlled trial was done in nine clinics in Johannesburg, South Africa. Participants (aged ≥18 years) undergoing investigation for tuberculosis were randomly assigned (1:1) to the intervention group or control group (standa…
Mgcini Moyo, Thobani Ntshiqa, Yohhei Hamada, Andrew Copas, Issa Sabi, et al.
…lines. **METHODS:** This is a pragmatic cluster-randomised trial conducted in Lesotho and Tanzania. Drug-sensitive TB (DS-TB) index patients aged ≥ 18 years, who have at least one contact, will be enrolled if they are microbiologically confirmed with TB…
Bethou Adhisivam, Chinnathambi Kamalarathnam, B Vishnu Bhat, Kumutha Jayaraman, Siva P Namachivayam, et al.
… **DESIGN:** Multicentre, open label, randomised controlled trial SETTING: Three tertiary neonatal intensive care units (NICUs) in southeast India. **POPULATION:** Newborn babies weighing <2000 g. 7067 were assessed for eligibility and 5420 were randomised (2714 BCG-OPV, 2706 co…
Qian Lei, Hao Wang, Liyun Dang, Xiaohui Lv, Xuejiao Zhou, et al.
…in (RFP) in drug-susceptible TB patients, and to assess its clinical effectiveness and safety through a pragmatic randomized controlled trial (PRCT). **METHODS:** A total of 489 TB patients undergoing first-line anti-TB treatment were enrolled and randomly assigned to a pha…
Nida Khan, Muhammad Ahmar Khan, Naila Muzaffar, Ahmad Ismail, Abdul Ghafoor, et al.
…S:** This is a stepped wedge, cluster randomized controlled trial with economic evaluation and health related quality of life sub-studies. Modified all-oral 9-month regimen will be sequentially rolled-out compared with the standard all-oral 11-month regimen at 12 sites in Punjab,…
Saskia Janssen, Thanakorn Vongjarudech, Mats O Karlsson, Caryn M Upton, Anthony J Garcia-Prats, et al.
…upporting broader access to the 3HP regimen. **PAN AFRICAN CLINICAL TRIALS REGISTRY:** PACTR202306775627089, registration date June 15, 2023.
David B Meya, Fiona V Cresswell, Biyue Dai, Nicole Engen, Kogieleum Naidoo, et al.
…We performed a double-blind, randomized, placebo-controlled clinical trial involving adults with tuberculous meningitis in Indonesia, South Africa, and Uganda. We assigned persons with and those without human immunodeficiency virus (HIV) coinfection to receive standard daily ison…
Dick Menzies, MD
… will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adult…
Nasur Buyinza, Kennedy Nkhoma, Eve Namisango, Matthew Maddocks, Julia Downing, et al.
…drug-resistant tuberculosis experience burdensome symptoms, clinical uncertainty, and high mortality. Palliative care is a designated essential health service under Universal Health Coverage. We aimed to test the hypothesis that receipt of additional nurse-led palliative care wou…
Dick Menzies, MD
The study is a pragmatic cluster randomized trial that is being conducted in 5 countries, with sites in 4 cities in Canada, Benin, Ghana, Indonesia and Vietnam. The unit of randomization is the health facility (24 health facilities randomized). The trial tests a complex intervent…
Gavin Churchyard, MD, PhD, Bernard Landry, MPH
…as a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10\^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to a second g…
Vanya Dhagat, MD
… tuberculosis infection. The study will be conducted at one clinical research site in India. The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "boost…
Souleymane Mboup, Robert Wilkinson, Bernard Landry
…(immunogenicity analysis set). This Phase II multi-country trial was conducted as a randomized, double-blind, placebo-controlled trial in 650 HIV-positive adults with no evidence of active TB disease. Subjects were stratified at the time of randomization by whether or not they w…
Amadou T LY
…mple size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children. MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M. tuberculosis. The clinical development consortium of this EDCTP program is preparin…
Angelique Luabeya, MD
…3 will enroll 9 subjects. This study is planned at a single clinical site in South Africa. The sizes specified for each study group were selected because they are judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I study rather than for stati…