Trial · NCT01785186
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media | 0 - 12 weeks | From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media. |
| Secondary | Frequency of Adverse Events | 0 - 12 weeks | All Adverse Events (AE), and AEs considered to be drug-related will coded using standard AE dictionaries. |
| Secondary | Mycobacteriology Identification and Characterization by PCR and MIC | 0 - 12 weeks | Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed as follows: * Identification of M. tuberculosis complex and RIF resistance by PCR (GeneXpert MTB/RIF®), * First-line drug susceptibility testing of the M. tuberculosis isolates using the MGIT system for sensitivity to rifampicin; isoniazid, pyrazinamide, moxifloxacin or ethambutol. * Minimum inhibitory concentrations (MIC) of SQ109, rifampicin and moxifloxacin. * Typing of the infecting strain(s) by molecular methods. |
| Secondary | Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding | 0 - 12 weeks | Pharmacokinetic parameters will be assessed for rifampicin, moxifloxacin and SQ109: * area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0-24) (in h\*ng/mL) * the observed maximum concentration (Cmax( (in ng/mL) * time to reach Cmax (Tmax)(in hours) * the minimum observed plasma concentration 24 hours following the last dose (Cmin) (in hours), * clearance (Cl) (in mL/minute), * volume of distribution (Vd) (in L), * elimination half-life (T1/2,) (in hours) * free (protein-unbound) fraction (for rifampicin only) (in percent). |
| Secondary | Pharmacodynamics Including AUC0-24/MIC (h*ng/mL) and Cmax/MIC (ng/mL) | 0 - 12 weeks | By combining pharmacokinetic parameters and MIC values (see below), the pharmacodynamic indices AUC0-24/MIC (h\*ng/mL) and Cmax/MIC (ng/mL) will be calculated for individual patients for experimental drugs administered. Pharmacokinetic parameters and pharmacodynamic indices will be related to efficacy and safety/tolerability endpoints. |
| Secondary | Time to First Negative Culture on Liquid and Solid Media | 0 - 12 weeks | Time to a convert to a single negative culture on liquid and solid media |
| Secondary | Proportion of Negative Sputum Cultures | 0 - 12 weeks | Proportion of patients converting to negative sputum culture (2 consecutive weekly cultures) in liquid and solid media |
| Secondary | Rate of Change in Time to Positivity | 0 - 12 weeks | Rate of change in time to positivity in BD MGIT 960® liquid culture |
| Secondary | Rate of Change in Quantitative PCR During Therapy | 0 - 12 weeks | GeneXpert MTB/RIF (Xpert) quantitative PCR results (counts per week |
| Secondary | Occurence of Treatment Failure (Relapse or Emergence of Drug-resistance) | 0 - 12 weeks | Frequency of treatment failures (number of patients with relapse and/or development of drug resistance) will be recorded |
| Secondary | Changes in Baseline Laboratory Safety Parameters During Treatment and Follow-up | 0 - 12 weeks | Frequency tables will be generated for visual acuity tests, 12 lead ECGs, clinical chemistry metrics, haematology, and urinalysis |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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