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  1. Article ; Online: Pharmacokinetic-Pharmacodynamic Evidence from a Phase 3 Trial to Support Flat-Dosing of Rifampicin for Tuberculosis.

    Ngo, Huy X / Xu, Ava Y / Velásquez, Gustavo E / Zhang, Nan / Chang, Vincent K / Kurbatova, Ekaterina V / Whitworth, William C / Sizemore, Erin / Bryant, Kia / Carr, Wendy / Weiner, Marc / Dooley, Kelly E / Engle, Melissa / Dorman, Susan E / Nahid, Payam / Swindells, Susan / Chaisson, Richard E / Nsubuga, Pheona / Lourens, Madeleine /
    Dawson, Rodney / Savic, Radojka M

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2024  

    Abstract: Background: The optimal dosing strategy for rifampicin in treating drug-susceptible tuberculosis (TB) is still highly debated. In the Phase 3 clinical trial Study 31/ACTG 5349 (NCT02410772), all participants in the control regimen arm received 600 mg ... ...

    Abstract Background: The optimal dosing strategy for rifampicin in treating drug-susceptible tuberculosis (TB) is still highly debated. In the Phase 3 clinical trial Study 31/ACTG 5349 (NCT02410772), all participants in the control regimen arm received 600 mg rifampicin daily as a flat dose. Here, we evaluated relationships between rifampicin exposure and efficacy and safety outcomes.
    Methods: We analyzed rifampicin concentration time profiles using population nonlinear mixed-effects models. We compared simulated rifampicin exposure from flat- and weight-banded dosing. We evaluated the effect of rifampicin exposure on stable culture conversion at 6 months, TB-related unfavorable outcomes at 9, 12, and 18 months using Cox proportional hazard models, and all trial-defined safety outcomes using logistic regression.
    Results: Our model derived rifampicin exposure ranged from 4.57 mg·h/L to 140.0 mg·h/L with a median of 41.8 mg·h/L. Pharmacokinetic simulations demonstrated that flat-dosed rifampicin provided exposure coverage similar to weight-banded dose. Exposure-efficacy analysis (N=680) showed that participants with rifampicin exposure below the median experienced similar hazards of stable culture conversion and TB-related unfavorable outcomes compared to those with exposure above the median. Exposure-safety analysis (N=722) showed that increased rifampicin exposure was not associated with increased grade 3 or higher adverse events, or serious adverse events.
    Conclusions: Flat-dosing of rifampicin at 600 mg daily may be a reasonable alternative to the incumbent weight-banded dosing strategy for the standard of care 6-month regimen. Future research should assess the optimal dosing strategy for rifampicin, at doses higher than the current recommendation.
    Language English
    Publishing date 2024-03-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciae119
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  2. Article ; Online: Liquid mycobacterial culture outcomes after different sputum collection techniques before and during treatment.

    Lourens, Madeleine / Philips, Lauren / Kleinhans, Carmen C / Friedrich, Sven O / Martinson, Neil / Venter, Amour / van der Merwe, Lize / Diacon, Andreas H

    Tuberculosis (Edinburgh, Scotland)

    2019  Volume 116, Page(s) 17–21

    Abstract: Setting: Mycobacterial sputum culture is a key diagnostic and research tool.: Objective: To compare mycobacterial culture outcomes of three sputum collection methods.: Design: We compared culture results within sets of three sputum samples ... ...

    Abstract Setting: Mycobacterial sputum culture is a key diagnostic and research tool.
    Objective: To compare mycobacterial culture outcomes of three sputum collection methods.
    Design: We compared culture results within sets of three sputum samples collected from 18 HIV-infected adult tuberculosis patients at regular intervals up to 84 days after treatment initiation. The first sputum was collected at home and brought to the clinic, where a second and third sputum were consecutively collected under supervision following mouthwash with bottled water and chlorhexidine solution respectively. All sputa were processed for liquid culture in duplicate.
    Results: Out of 556 cultures 430 (77.3%), 91 (16.4%) and 35 (6.3%) were positive, negative or contaminated, respectively. The odds of contamination were higher with home collection and with water rinse than with chlorhexidine rinse (OR: 12.5, p < 0.001 and OR: 6.7, p = 0.015). Chlorhexidine rinse increased the odds of a negative culture compared to water rinse (OR: 3.5, p = 0.002). The odds of a positive culture were greater with water rinse than with home collection (OR: 2.5, p = 0.005). Water rinse significantly reduced time to culture positivity.
    Conclusion: Compared to sputum collected at home, chlorhexidine rinse reduces culture contamination and water rinse increases the rate and viable mycobacterial load of positive cultures.
    MeSH term(s) Adult ; Antitubercular Agents/therapeutic use ; Bacteriological Techniques ; Chlorhexidine/administration & dosage ; Coinfection ; Drinking Water ; Female ; HIV Infections/diagnosis ; Humans ; Male ; Microbial Viability ; Mouthwashes/administration & dosage ; Mycobacterium tuberculosis/drug effects ; Mycobacterium tuberculosis/growth & development ; Mycobacterium tuberculosis/isolation & purification ; Predictive Value of Tests ; Reproducibility of Results ; Specimen Handling/methods ; Sputum/microbiology ; Time Factors ; Treatment Outcome ; Tuberculosis, Pulmonary/diagnosis ; Tuberculosis, Pulmonary/drug therapy ; Tuberculosis, Pulmonary/microbiology
    Chemical Substances Antitubercular Agents ; Drinking Water ; Mouthwashes ; Chlorhexidine (R4KO0DY52L)
    Language English
    Publishing date 2019-03-28
    Publishing country Scotland
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2046804-0
    ISSN 1873-281X ; 1472-9792
    ISSN (online) 1873-281X
    ISSN 1472-9792
    DOI 10.1016/j.tube.2019.03.008
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  3. Article ; Online: Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household.

    Kim, Soyeon / Hesseling, Anneke C / Wu, Xingye / Hughes, Michael D / Shah, N Sarita / Gaikwad, Sanjay / Kumarasamy, Nishi / Mitchell, Erika / Leon, Mey / Gonzales, Pedro / Badal-Faesen, Sharlaa / Lourens, Madeleine / Nerette, Sandy / Shenje, Justin / de Koker, Petra / Nedsuwan, Supalert / Mohapi, Lerato / Chakalisa, Unoda A / Mngqbisa, Rosie /
    Escada, Rodrigo Otávio da Silva / Ouma, Samuel / Heckman, Barbara / Naini, Linda / Gupta, Amita / Swindells, Susan / Churchyard, Gavin

    PloS one

    2023  Volume 18, Issue 3, Page(s) e0283290

    Abstract: Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact ... ...

    Abstract Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact investigations.
    Methods: Using data from a cross-sectional study that enrolled index participants with rifampin-resistant pulmonary TB and their household contacts (HHCs), we evaluated HHCs age ≥15 years for factors associated with two outcomes: Mycobacterium tuberculosis infection and TB disease. Among HHCs who were not already diagnosed with current active TB disease by the TB program, Mycobacterium tuberculosis infection was determined by interferon-gamma release assay (IGRA). TB disease was adjudicated centrally. We fitted logistic regression models using generalized estimating equations.
    Results: Seven hundred twelve HHCs age ≥15 years enrolled from 279 households in eight high-TB burden countries were a median age of 34 years, 63% female, 22% current smokers and 8% previous smokers, 8% HIV-positive, and 11% previously treated for TB. Of 686 with determinate IGRA results, 471 tested IGRA positive (prevalence 68.8% (95% Confidence Interval: 64.6%, 72.8%)). Multivariable modeling showed IGRA positivity was more common in HHCs aged 25-49 years; reporting prior TB treatment; reporting incarceration, substance use, and/or a period of daily alcohol use in the past 12 months; sharing a sleeping room or more evenings spent with the index participant; living with smokers; or living in a home of materials typical of low socioeconomic status. Forty-six (6.5% (95% Confidence Interval: 4.6%, 9.0%)) HHCs age ≥15 years had prevalent TB disease. Multivariable modeling showed higher prevalence of TB disease among HHCs aged ≥50 years; reporting current or previous smoking; reporting a period of daily alcohol use in the past 12 months; and reporting prior TB treatment.
    Conclusion: We identified overlapping and distinct characteristics associated with Mycobacterium tuberculosis infection and TB disease that may be useful for those conducting household TB investigations.
    MeSH term(s) Adolescent ; Adult ; Female ; Humans ; Male ; Cross-Sectional Studies ; Mycobacterium tuberculosis ; Rifampin/therapeutic use ; Risk Factors ; Tuberculin Test ; Tuberculosis/epidemiology ; Tuberculosis, Pulmonary/drug therapy ; Tuberculosis, Pulmonary/epidemiology ; Tuberculosis, Pulmonary/diagnosis ; Drug Resistance, Bacterial
    Chemical Substances Rifampin (VJT6J7R4TR)
    Language English
    Publishing date 2023-03-17
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0283290
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  4. Article ; Online: A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials.

    Kurbatova, Ekaterina V / Phillips, Patrick P J / Dorman, Susan E / Sizemore, Erin E / Bryant, Kia E / Purfield, Anne E / Ricaldi, Jessica / Brown, Nicole E / Johnson, John L / Wallis, Carole L / Akol, Joseph P / Ocheretina, Oksana / Van Hung, Nguyen / Mayanja-Kizza, Harriet / Lourens, Madeleine / Dawson, Rodney / Nhung, Nguyen Viet / Pierre, Samuel / Musodza, Yeukai /
    Shenje, Justin / Badal-Faesen, Sharlaa / Vilbrun, Stalz Charles / Waja, Ziyaad / Peddareddy, Lakshmi / Scott, Nigel A / Yuan, Yan / Goldberg, Stefan V / Swindells, Susan / Chaisson, Richard E / Nahid, Payam

    American journal of respiratory and critical care medicine

    2023  Volume 207, Issue 10, Page(s) 1376–1382

    Abstract: Rationale: ...

    Abstract Rationale:
    MeSH term(s) Humans ; Antitubercular Agents/therapeutic use ; Tuberculosis/drug therapy ; Tuberculosis, Pulmonary/drug therapy ; Tuberculosis, Pulmonary/microbiology
    Chemical Substances Antitubercular Agents
    Language English
    Publishing date 2023-02-14
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.202206-1118OC
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  5. Article ; Online: C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.

    Aggerbeck, Henrik / Ruhwald, Morten / Hoff, Søren T / Borregaard, Bettine / Hellstrom, Elizabeth / Malahleha, Mookho / Siebert, Mirna / Gani, Mashra / Seopela, Vincent / Diacon, Andreas / Lourens, Madeleine / Andersen, Peter / Dheda, Keertan

    PloS one

    2018  Volume 13, Issue 9, Page(s) e0204554

    Abstract: Background: C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons.: Methods: ... ...

    Abstract Background: C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons.
    Methods: Asymptomatic South African contacts <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres. C-Tb and TST were allocated to either forearm double blinded. Samples for QFT were collected in parallel, and test-positivity rates were compared.
    Results: In participants with microbiologically confirmed TB (n = 75; 45% HIV-infected) sensitivity of C-Tb, TST and QFT were similar (72% versus 75% versus 73%; p>0.5). All 3 tests had similar positivity rates in HIV-infected participants with active TB, however, positivity rates were reduced when CD4 counts were <100 cells/μL. In participants where active TB was excluded (n = 920), C-Tb (41%), TST (43%), and QFT (44%) also had similar test-positivity rates. Among asymptomatic contacts aged below five, 32% (28/87) tested positive with C-Tb and 32% (28/87) with TST (concordance 89%). Overall, C-Tb and TST showed a similar safety profile.
    Conclusion: C-Tb was safe and showed similar test-positivity rates, compared to TST and QFT, in children and HIV-infected persons with active or latent M. tuberculosis infection. These data inform the utility of C-Tb in clinical practice.
    Trial registration: ClinicalTrials.gov NCT01642888. EudraCT 2011-005078-40.
    MeSH term(s) Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Coinfection/diagnosis ; Double-Blind Method ; Female ; HIV Infections/complications ; HIV Infections/diagnosis ; Humans ; Infant ; Infant, Newborn ; Male ; Middle Aged ; Sensitivity and Specificity ; Skin Tests/methods ; Tuberculosis/complications ; Tuberculosis/diagnosis ; Young Adult
    Language English
    Publishing date 2018-09-24
    Publishing country United States
    Document type Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0204554
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  6. Article ; Online: Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis.

    Dorman, Susan E / Nahid, Payam / Kurbatova, Ekaterina V / Phillips, Patrick P J / Bryant, Kia / Dooley, Kelly E / Engle, Melissa / Goldberg, Stefan V / Phan, Ha T T / Hakim, James / Johnson, John L / Lourens, Madeleine / Martinson, Neil A / Muzanyi, Grace / Narunsky, Kim / Nerette, Sandy / Nguyen, Nhung V / Pham, Thuong H / Pierre, Samuel /
    Purfield, Anne E / Samaneka, Wadzanai / Savic, Radojka M / Sanne, Ian / Scott, Nigel A / Shenje, Justin / Sizemore, Erin / Vernon, Andrew / Waja, Ziyaad / Weiner, Marc / Swindells, Susan / Chaisson, Richard E

    The New England journal of medicine

    2021  Volume 384, Issue 18, Page(s) 1705–1718

    Abstract: Background: Rifapentine-based regimens have potent antimycobacterial activity that may allow for a shorter course in patients with drug-susceptible pulmonary tuberculosis.: Methods: In an open-label, phase 3, randomized, controlled trial involving ... ...

    Abstract Background: Rifapentine-based regimens have potent antimycobacterial activity that may allow for a shorter course in patients with drug-susceptible pulmonary tuberculosis.
    Methods: In an open-label, phase 3, randomized, controlled trial involving persons with newly diagnosed pulmonary tuberculosis from 13 countries, we compared two 4-month rifapentine-based regimens with a standard 6-month regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (control) using a noninferiority margin of 6.6 percentage points. In one 4-month regimen, rifampin was replaced with rifapentine; in the other, rifampin was replaced with rifapentine and ethambutol with moxifloxacin. The primary efficacy outcome was survival free of tuberculosis at 12 months.
    Results: Among 2516 participants who had undergone randomization, 2343 had a culture positive for
    Conclusions: The efficacy of a 4-month rifapentine-based regimen containing moxifloxacin was noninferior to the standard 6-month regimen in the treatment of tuberculosis. (Funded by the Centers for Disease Control and Prevention and others; Study 31/A5349 ClinicalTrials.gov number, NCT02410772.).
    MeSH term(s) Adolescent ; Adult ; Antibiotics, Antitubercular/administration & dosage ; Antibiotics, Antitubercular/adverse effects ; Antitubercular Agents/adverse effects ; Antitubercular Agents/therapeutic use ; Child ; Confidence Intervals ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Humans ; Male ; Moxifloxacin/administration & dosage ; Moxifloxacin/adverse effects ; Mycobacterium tuberculosis/isolation & purification ; Rifampin/administration & dosage ; Rifampin/adverse effects ; Tuberculosis, Pulmonary/drug therapy ; Young Adult
    Chemical Substances Antibiotics, Antitubercular ; Antitubercular Agents ; Moxifloxacin (U188XYD42P) ; Rifampin (VJT6J7R4TR)
    Language English
    Publishing date 2021-05-05
    Publishing country United States
    Document type Clinical Trial, Phase III ; Comparative Study ; Equivalence Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa2033400
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