Trial · NCT01785186

Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design

NCT01785186, Phase 2, Completed, Michael Hoelscher; results first posted 2017-09-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design. Trials, record NCT01785186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785186

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
NCT number: NCT01785186
Status: Completed
Phases: Phase 2
Enrollment: 365 participants, actual
Lead sponsor: Michael Hoelscher
Conditions: Tuberculosis, Pulmonary
Interventions: SQ109, Rifampicin, Moxifloxacin, isoniazid, pyrazinamide, ethambutol, pyridoxine
First posted: 2013-02-07
Last updated: 2017-09-20
Results first posted: 2017-09-20

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	0 - 12 weeks	Modified intention to treat analysis	days	MEDIAN
SECONDARY	Frequency of Adverse Events	0 - 12 weeks		participants	NUMBER
SECONDARY	Mycobacteriology Identification and Characterization by PCR and MIC	0 - 12 weeks
SECONDARY	Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding	0 - 12 weeks	Pharmacokinetic population	Rifampicin AUC(mg*h/l)	GEOMETRIC_MEAN
SECONDARY	Pharmacodynamics Including AUC0-24/MIC (h*ng/mL) and Cmax/MIC (ng/mL)	0 - 12 weeks
SECONDARY	Time to First Negative Culture on Liquid and Solid Media	0 - 12 weeks
SECONDARY	Proportion of Negative Sputum Cultures	0 - 12 weeks
SECONDARY	Rate of Change in Time to Positivity	0 - 12 weeks
SECONDARY	Rate of Change in Quantitative PCR During Therapy	0 - 12 weeks
SECONDARY	Occurence of Treatment Failure (Relapse or Emergence of Drug-resistance)	0 - 12 weeks

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	Arm 1 (R35)		48	Inter-Quartile Range 34 to 69	days
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	HRZQ		63	Inter-Quartile Range 48 to 83	days
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	HR20ZQ		66	Inter-Quartile Range 41 to 83	days
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	HR20ZM		55	Inter-Quartile Range 41 to 69	days
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media	HRZE		62	Inter-Quartile Range 41 to 83	days
Frequency of Adverse Events	Arm 1 (R35)	Number of Patients with at least 1 AE	53		participants
Frequency of Adverse Events	HRZQ	Number of Patients with at least 1 AE	49		participants
Frequency of Adverse Events	HR20ZQ	Number of Patients with at least 1 AE	42		participants
Frequency of Adverse Events	HR20ZM	Number of Patients with at least 1 AE	49		participants
Frequency of Adverse Events	HRZE	Number of Patients with at least 1 AE	92		participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HRZQ	59
Overall Study	STARTED	Arm 1 (R35)	63
Overall Study	STARTED	HR20ZQ	57
Overall Study	STARTED	HR20ZM	63
Overall Study	STARTED	HRZE	123
Overall Study	COMPLETED	HRZQ	53
Overall Study	COMPLETED	Arm 1 (R35)	57
Overall Study	COMPLETED	HR20ZQ	52
Overall Study	COMPLETED	HR20ZM	58
Overall Study	COMPLETED	HRZE	117

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events1,105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	HRZQ	3	59	3
other	Abdominal pain	Gastrointestinal disorders	Arm 1 (R35)	1	63	1
other	Abdominal pain	Gastrointestinal disorders	HR20ZQ	2	57	2
other	Abdominal pain	Gastrointestinal disorders	HR20ZM	2	63	2
other	Abdominal pain	Gastrointestinal disorders	HRZE	1	123	1
other	Abdominal pain upper	Gastrointestinal disorders	HRZQ	0	59	0
other	Abdominal pain upper	Gastrointestinal disorders	Arm 1 (R35)	0	63	0
other	Abdominal pain upper	Gastrointestinal disorders	HR20ZQ	1	57	1
other	Abdominal pain upper	Gastrointestinal disorders	HR20ZM	0	63	0
other	Abdominal pain upper	Gastrointestinal disorders	HRZE	0	123	0

1 to 10 of 1,105Source ClinicalTrials.gov

See all 1,105 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HRZQ
Total, all-cause mortality	Arm 1 (R35)
Total, all-cause mortality	HR20ZQ
Total, all-cause mortality	HR20ZM
Total, all-cause mortality	HRZE
Total, other adverse events	HRZQ	49	59
Total, other adverse events	Arm 1 (R35)	53	63
Total, other adverse events	HR20ZQ	42	57
Total, other adverse events	HR20ZM	49	63
Total, other adverse events	HRZE	92	123

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28100438	DERIVED	PubMed
33542052	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01785186

GET https://conductscience.org/api/trials/v1/NCT01785186/events?page=2

API reference For AI assistants