Showing 1–25 of 30 documents
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Silvia S Chiang, Jonathon R Campbell, Daniele Maria Pelissari, Márcia C Bellotti de Oliveira, Anna Cristina C Carvalho, et al.
…rculosis (TB) annually. Little is known about the impact of pregnancy on TB outcomes. **METHODS:** This study used surveillance data from Brazil's Ministry of Health. We included women aged 11-49 years newly diagnosed with drug-susceptible TB disease between 2016 and 2022, treat…
Van Schalkwyk M, Bekker A, Decloedt E, Wang J, Theron GB, et al.
Physiological changes during pregnancy may alter the pharmacokinetics (PK) of antituberculosis drugs. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026s was a multicenter, phase IV, observational, prospective PK and safety study of antiretroviral …
Korri R, Bakuli A, Owolabi OA, Lalashowi J, Azize C, et al.
…l and reproductive health (SRH) outcomes, including ectopic pregnancy and perinatal mortality. The data presented here is from the TB Sequel observational cohort conducted in four African countries. For this sub-study, we selected only female participants, who were diagnosed with…
Chihota V, Gombe M, Gupta A, Salazar-Austin N, Ryckman T, et al.
…al outcomes, and newer regimens have not yet been tested in pregnancy. New formulations of rifapentine-based TPT have been developed, and the cost has been radically reduced. Innovative models of delivery to support the scale up of TPT have been developed. Modeling suggests that …
Loveday M, Gandhi NR, Khan PY, Theron G, Hlangu S, et al.
…of infants born to mothers treated for drug resistant TB in pregnancy. Critical case history assessment is important to identify risks and guide clinical practice. Methods In a cohort of pregnant women with multidrug or rifampicin resistant (MDR/RR)-TB enrolled between 1 January …
Muhammed S Bah, Kyaw Ko Ko Htet, Gregory P Bisson, Celso Khosa, Refiloe Masekela, et al.
…actor with the four most recommended being HIV/AIDS (100%), pregnancy (73%) and liver disease (59%) and mental health (59%). Recommendations for linkage to care were more infrequent and also varied with the top four being HIV (88%), liver disease (47%), diabetes (44%), and mental…
Dereck Tait, MBChB
This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in HIV-ne…
University of Virginia
Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug …
Radojka Savic, PharmD, PhD, Kelly Dooley, MD, PhD, Gustavo Velásquez, MD, MPH
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens…
Eric Nuermberger, MD
A seamless, staged Phase II/III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks o…
National Institute of Allergy and Infectious Diseases (NIAID)
A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB. This is an open-label, single arm, phase II, multicenter PK study to investigate the …
Marissa Russell
This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups. * H56:IC31 (investigational vaccine) * Placebo 900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics…
John Metcalfe, MD, PhD, MPH
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB). This study compared a 3-month rifapentine (RPT)/clofazim…
Marx FM, Cohen T, Lombard C, Hesseling AC, Dlamini SS, et al.
OBJECTIVE: To investigate the extent to which relapse and other previously treated tuberculosis (TB) contribute to the notified TB burden in South Africa. DESIGN: We conducted an ecological analysis at the level of the 52 South African health districts using national electronic T…
Carole D Mitnick, Sc.D, Geraint Davies, B.M., Ph.D
The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood conce…
Nicole Salazar-Austin, MD, ScM
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as e…
Anushka Naidoo, PhD, Kelly Dooley, MD, Kogieleum Naidoo, PhD
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving …
Gustavo Velásquez, MD, MPH, Patrick Phillips, PhD, Susan Dorman, MD
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then …
Beijing Chest Hospital
The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older. The main questions it aims to answer are: What is the proportion of participants with a f…
Katarina Niward, MD, PhD
Tuberculosis (TB) treatment is long and complex with the risk of poor treatment adherence and treatment failure. Several attempts to shorten treatment of drug-susceptible TB have been unsuccessful. However, recent data support a shortened regimen for mild and moderate pulmonary T…
Daniel W Fitzgerald, MD, Carl Nathan, MD, Jean William Pape, MD
This research is being done to determine if Nitazoxanide (NTZ) will cause a significant decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The study is being conducted at the GHESKIO Centers in Port au Prince Haiti This is a prospective rand…
Serena Koenig, MD, MPH, Sean Wasserman, MBChB, PhD
The PRESCIENT trial is a Phase IIc, open-label, randomized trial that will compare a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible pulmonary tuberculosis. Eligible participants will be…
Jason Farley, PhD, MPH, ANP-BC, Denise Evans, PhD, Norbert Ndjeka, MBChB
The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB treatment at district hospitals in the provinces of Kw…
Shenzhen Third People's Hospital
Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. PAN-…
Veronique R de Jager, MD, Prof. Rodney Dawson, MD, Prof. Andreas Diacon
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).