TuberculosisPhase 1NCT05586230
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
A Phase 1 study testing Pretomanid and Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) in people with Tuberculosis and Rifampicin Resistant Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages Up to 17 years, women only
- Conditions the study is for
- Tuberculosis, Rifampicin Resistant Tuberculosis
- What is being tested?
- Pretomanid and Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 3 Oct 2023to 28 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- If not of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures: Parent/legal guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per IRB/EC policies and procedures, potential participant is willing and able to provide written assent for study participation.
- If of legal age or circumstance to provide independent informed consent as determined by site SOPs and consistent with IRB/EC policies and procedures: Potential participant is willing and able to provide written informed consent for study participation.
- Note: All sites must follow all applicable IRB/EC policies and procedures.
- Assigned female sex at birth, as determined by the site investigator based on participant and parent/guardian report and available medical records
- Age less than 18 years of age at entry
- Note: Neonates (defined as children who are 28 days of age or younger [≤28 days of age]) may be allowed to enroll after CMC and SMC evaluation of safety and PK data at the interim analysis.
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- Weight greater than or equal to 4 kg at entry
- Has confirmed or probable intrathoracic (pulmonary) RR-TB and/or any form of extrathoracic (extrapulmonary) RR-TB (other than stage 2 or 3 TB meningitis, which is exclusionary)
- Confirmed intrathoracic (pulmonary) RR-TB, based on chest radiograph and/or symptoms consistent with TB, and/or any forms of extrathoracic TB, with all of the following, as determined by the site investigator based on medical records:
- Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods
- Rifampicin resistance demonstrated by genotypic (molecular) or phenotypic methods
- Documented clinical decision to treat for RR-TB
- Note: In the case of discrepant genotypic and phenotypic test results (i.e., rifampicin-susceptible by one method and rifampicin-resistant by another), this criterion will be considered to have been met if at least one rifampicin-resistant result is available and the participant is assessed as having RR-TB by the non-study care provider when study staff evaluate the participant for eligibility.
- Probable intrathoracic (pulmonary) RR-TB, based on chest radiograph and/or symptoms consistent with TB, and/or any form of extrathoracic TB, with both of the following, as determined by the site investigator based on medical records:
- Documented exposure to a source case with bacteriologically-confirmed intrathoracic rifampicin-resistant TB
- Documented clinical decision to treat for RR-TB
- Note: Full resistance profiles may be obtained after study entry.
- Initiated an appropriate TB OBR treatment regimen as per routine treatment decision, at least two weeks prior to entry, as determined by the site investigator based on medical records, and is tolerating the regimen well at entry, in the opinion of the site investigator
- Note: see exclusion criterion below for exclusionary TB medications
- Has normal, grade 1, or grade 2 results for all of the following at screening (i.e., from specimens collected within 28 days prior to entry), based on grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table; refer to protocol for guidance on severity grading):
- Creatinine
- Platelets
- Absolute neutrophil count
- Hemoglobin
- Estimated glomerular filtration rate (eGFR; bedside Schwartz formula)
- Note: Laboratory tests may be repeated during the study screening period (i.e., within 28 days prior to entry), with the latest results used for eligibility determination.
- Has normal or grade 1 results for all of the following at screening (i.e., from specimens collected within 28 days prior to entry), based on grading per the DAIDS AE Grading Table (refer to protocol for guidance on severity grading):
- Alanine aminotransferase (ALT)
- Lipase
- Total bilirubin
- Note: Laboratory tests may be repeated during the study screening period (i.e., within 28 days prior to entry), with the latest results used for eligibility determination.
- Has a normal QT interval corrected by Fridericia's formula (QTcF) (mean interval value less than 450 milliseconds, on ECG performed in triplicate) at screening
- Note: The mean QTcF value obtained from the centralized ECG reading must be used for eligibility determination.
- Has a Karnofsky score greater than or equal to 50% for participants 16 years of age and older or Lansky play score greater than or equal to 50% for participants less than 16 years of age, at screening
- Does not have severe acute malnutrition, defined below, and has no presence of nutritional edema, based on physical examination, at screening
- Severe acute malnutrition is defined as any of the following:
- For participants 5 years of age and younger: weight-for-height z-score less than -3, according to WHO growth standards
- For participants 6 months to 5 years of age: mid-upper arm circumference (MUAC) less than 115 mm
- For participants older than 5 years of age: BMI z-score less than -3, according to WHO growth standards
- Note: Children who are stunted may be enrolled.
- HIV status determined based on testing methods meeting the requirements specified in protocol
- For participants living with HIV, has been taking a stable ARV regimen for at least two consecutive weeks at entry, as determined by the site investigator based on participant and parent/guardian report and available medical records
- Note: Dose and formulation changes (e.g., for growth) within the two weeks prior to entry are permitted. See below for exclusionary ARVs.
- For participants who have reached menarche or who are engaging in sexual activity (self-reported): not pregnant based on testing performed within 5 days prior to entry during the study screening period (i.e., within 28 days prior to entry)
- For participants who are engaging in sexual activity (self-reported): agrees to use at least one effective, medically accepted birth control method while on study, based on participant and parent/guardian report at entry
- Expected to be available for two weeks of study participation, based on participant and parent/guardian report at entry
Who cannot join
- Has tuberculosis meningitis Stage 2 or 3, as determined by the site investigator based on medical records
- Receipt of any of the following, within 14 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
- Rifamycins
- Any prohibited medication (see protocol for listing)
- For participants living with HIV: ritonavir-boosted protease inhibitors (e.g., ritonavir-boosted lopinavir, ritonavir-boosted darunavir), atazanavir, nevirapine etravirine, efavirenz, or cobicistat
- Receipt of any investigational agent or device within 28 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
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- Note: Co-enrollment in COVID-19 vaccine studies and receipt of a COVID-19 vaccine under emergency use authorization (or local equivalent) is allowed, with prior approval from the CMC.
- Note: Any co-enrollment must be approved as noted in protocol
- Has any of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records
- Clinical evidence of acute hepatitis A, B, C, or chronic hepatitis B or C
- Significant cardiac arrhythmia that requires medication or increases the risk for Torsade de Pointes
- Known allergy or hypersensitivity to pretomanid or other nitroimidazole compounds
- Known porphyria
- Currently breastfeeding an infant at entry, as determined by the site investigator based on participant/parent/guardian report
- Exposed to pretomanid through breast milk within seven days prior to entry (i.e., mother receiving pretomanid and breastfeeding a potential participant), as determined by the site investigator based on parent/guardian report
- Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
South Africa3 sites
Site 31790, Desmond Tutu TB Centre (DTTC) CRS
Cape Town
Site 31929, Sizwe CRS
Johannesburg
Site 31976, PHRU Matlosana CRS
Klerksdorp, North West, 2574
Brazil1 site
Site 5071, Instituto de Puericultura e Pediatria Martagao Gesteira CRS
Rio de Janeiro
Thailand1 site
Site 5115, Siriraj Hospital, Mahidol University NICHD CRS
Bangkok Noi
About this study
Official title: Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).
Read the detailed description
This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a single-dose of pretomanid added to an OBR in infants, children, and adolescents with RR-TB. The term children is used within the protocol to indicate the total age range from infants through adolescents; enrollment will be limited to children assigned female sex at birth and enrollment of neonates will be deferred until safety and pharmacokinetic data are available in older groups, pending review by the CMC and SMC during the interim analysis. Refer to the study design and the study eligibility criteria and a description of the study recruitment, screening, and enrollment process. Participants are expected to be enrolled at study sites in Brazil, India, South Africa and Thailand. Up to 72 participants will be enrolled to achieve at least nine evaluable participants in each of four weight groups, for a total of at least 36 enrolled participants.
Participants will receive a single dose of pretomanid on the day of study entry. No additional doses of pretomanid will be administered; participants will continue their OBR. Intensive PK sampling and safety monitoring will be performed on the day of study entry and over the course of the next 48 hours. Participants will then complete a final study visit approximately two weeks after study entry.
- Conditions
- Tuberculosis, Rifampicin Resistant Tuberculosis
- Being tested
- Pretomanid, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PretomanidDrug
Also called Pa
Administered orally based on participant's weight
Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)Drug
Non-study prescribed OBR will vary according to local, national and/or international guidelines for treatment of children with MDR-TB. Administered in addition to single dose of Pa.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (≥ 31 kg) | Experimental | ≥40 kg (Adult Formulation)
31-<40 kg (Dispersible Pediatric Formulation) Receives: Drug: Pretomanid; Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) |
| Group 2 (20-<31 kg) | Experimental | 20-<31 kg (Dispersible pediatric Formulation) Receives: Drug: Pretomanid; Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) |
| Group 3 (12-<20 kg) | Experimental | 12-<20 kg (Dispersible pediatric Formulation) Receives: Drug: Pretomanid; Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) |
| Group 4 (4-<12 kg) | Experimental | 8-<12 kg (Dispersible pediatric Formulation)
6-<8 kg (Dispersible pediatric Formulation)
4-<6 kg (Dispersible pediatric Formulation) Receives: Drug: Pretomanid; Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Area under the curve from start of dose to infinity from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
CL/F
apparent clearance from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
AUC0-tlast
Area under curve-Last measure concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
AUC0-48
Area under the curve from time zero to 48 hours from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
Tmax
Time of maximal concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
Cmax
Peak concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Measured: Through 48 hours
Secondary outcomes (5)
Number of participants with an adverse event
Measured: From time of single Pa dose at study entry to study week 2
Number of participants with a Grade 3 or higher adverse event
Measured: From time of single Pa dose at study entry to study week 2
Number of participants with a grade 2 or higher adverse event assessed as related to study drug
Measured: From time of single Pa dose at study entry to study week 2
Number of participants with a serious adverse event
Measured: From time of single Pa dose at study entry to study week 2
Aggregated data on parent/guardian and/or participant (and/or study staff) reported palatability and acceptability of study drug given as single dose at entry
Based on questionnaire responses
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start3 Oct 2023
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ethel Weld, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586230
- Sponsor's protocol ID
- IMPAACT 2034
- Other IDs
- 38754
- Status last verified
- May 2026
- First submitted
- 11 Oct 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
- ClinicalTrials.gov ID
- NCT05586230
- Acronym / sponsor ID
- IMPAACT 2034
- Conditions
- Tuberculosis, Rifampicin Resistant Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).
Detailed description
This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a single-dose of pretomanid added to an OBR in infants, children, and adolescents with RR-TB. The term children is used within the protocol to indicate the total age range from infants through adolescents; enrollment will be limited to children assigned female sex at birth and enrollment of neonates will be deferred until safety and pharmacokinetic data are available in older groups, pending review by the CMC and SMC during the interim analysis. Refer to the study design and the study eligibility criteria and a description of the study recruitment, screening, and enrollment process. Participants are expected to be enrolled at study sites in Brazil, India, South Africa and Thailand. Up to 72 participants will be enrolled to achieve at least nine evaluable participants in each of four weight groups, for a total of at least 36 enrolled participants.
Participants will receive a single dose of pretomanid on the day of study entry. No additional doses of pretomanid will be administered; participants will continue their OBR. Intensive PK sampling and safety monitoring will be performed on the day of study entry and over the course of the next 48 hours. Participants will then complete a final study visit approximately two weeks after study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (≥ 31 kg) | Experimental | Drug: Pretomanid, Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)≥40 kg (Adult Formulation) 31-<40 kg (Dispersible Pediatric Formulation) |
| Group 2 (20-<31 kg) | Experimental | Drug: Pretomanid, Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)20-<31 kg (Dispersible pediatric Formulation) |
| Group 3 (12-<20 kg) | Experimental | Drug: Pretomanid, Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)12-<20 kg (Dispersible pediatric Formulation) |
| Group 4 (4-<12 kg) | Experimental | Drug: Pretomanid, Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)8-<12 kg (Dispersible pediatric Formulation) 6-<8 kg (Dispersible pediatric Formulation) 4-<6 kg (Dispersible pediatric Formulation) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (46 listed)
- If not of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures: Parent/legal guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per IRB/EC policies and procedures, potential participant is willing and able to provide written assent for study participation.
- If of legal age or circumstance to provide independent informed consent as determined by site SOPs and consistent with IRB/EC policies and procedures: Potential participant is willing and able to provide written informed consent for study participation.
- Note: All sites must follow all applicable IRB/EC policies and procedures.
- Assigned female sex at birth, as determined by the site investigator based on participant and parent/guardian report and available medical records
- Age less than 18 years of age at entry
Key exclusion criteria (16 listed)
- Has tuberculosis meningitis Stage 2 or 3, as determined by the site investigator based on medical records
- Receipt of any of the following, within 14 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
- Receipt of any investigational agent or device within 28 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
- Note: Co-enrollment in COVID-19 vaccine studies and receipt of a COVID-19 vaccine under emergency use authorization (or local equivalent) is allowed, with prior approval from the CMC.
- Note: Any co-enrollment must be approved as noted in protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PretomanidAlso: PaAdministered orally based on participant's weight | Drug | Group 1 (≥ 31 kg), Group 2 (20-<31 kg), Group 3 (12-<20 kg), Group 4 (4-<12 kg) |
| Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)Non-study prescribed OBR will vary according to local, national and/or international guidelines for treatment of children with MDR-TB. Administered in addition to single dose of Pa. | Drug | Group 1 (≥ 31 kg), Group 2 (20-<31 kg), Group 3 (12-<20 kg), Group 4 (4-<12 kg) |
Primary outcome
AUC0-∞
Time frame: Through 48 hours
Area under the curve from start of dose to infinity from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
CL/F
Time frame: Through 48 hours
apparent clearance from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
AUC0-tlast
Time frame: Through 48 hours
Area under curve-Last measure concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
AUC0-48
Time frame: Through 48 hours
Area under the curve from time zero to 48 hours from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Tmax
Time frame: Through 48 hours
Time of maximal concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
Cmax
Time frame: Through 48 hours
Peak concentration from start of dose to 48 hours post-dose. Measured from study entry to Day 2. Blood samples were drawn at 1, 3, 6, 9, 24 and 48 hours post dose
5 secondary outcomes
Number of participants with an adverse event
Time frame: From time of single Pa dose at study entry to study week 2
Number of participants with a Grade 3 or higher adverse event
Time frame: From time of single Pa dose at study entry to study week 2
Number of participants with a grade 2 or higher adverse event assessed as related to study drug
Time frame: From time of single Pa dose at study entry to study week 2
Number of participants with a serious adverse event
Time frame: From time of single Pa dose at study entry to study week 2
Aggregated data on parent/guardian and/or participant (and/or study staff) reported palatability and acceptability of study drug given as single dose at entry
Time frame: At day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethel Weld study chair
Johns Hopkins University
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pretomanid and Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) in people with Tuberculosis and Rifampicin Resistant Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, Brazil, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: Through 48 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.