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Nitroimidazole

PA-824 for Tuberculosis

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1, 2, 5, and 12
Awards & highlights

Study Summary

This trial is testing the effects of a new drug, Pretomanid, on people with different levels of liver damage. There will be approximately 36 people in the study, and it will last for 24 months. The primary objective is to see how Pretomanid affects people with different levels of liver damage, and the secondary objective is to see if Pretomanid is safe for people with different levels of liver damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -1, 2, 5, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1, 2, 5, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC(0-infinity): Area under the concentration time-curve extrapolated to infinity at specified pre-dose and post-dose time points
AUC(0-last): Area under the concentration time-curve to the last concentration above the lower limit of quantitation at specified pre-dose and post-dose time points
CL/F: Apparent oral clearance calculated from Dose/AUC(0-infinifty) at specified pre-dose and post-dose time points
+4 more
Secondary outcome measures
Incidence of related adverse events
Incidence of serious adverse events
Severity of related adverse events
+5 more

Side effects data

From 2018 Phase 3 trial • 284 Patients • NCT02342886
31%
Arthralgia
31%
Pleuritic pain
23%
Neuropathy peripheral
15%
Pulmonary embolism
15%
Headache
15%
Nausea
15%
Abdominal pain
15%
Dizziness
15%
Vomiting
15%
Pruritus
15%
Hyperuricaemia
15%
Haemoptysis
8%
Protein urine present
8%
Burning sensation
8%
Atrial fibrillation
8%
Pneumonia
8%
Myocarditis
8%
Eyelid haematoma
8%
Cardiac ventricular thrombosis
8%
Alanine aminotransferase increased
8%
Hypotension
8%
Diarrhoea
8%
Lower respiratory tract infection
8%
Upper respiratory tract infection
8%
Toothache
8%
Pneumothorax spontaneous
8%
Pulmonary oedema
8%
Lung cancer metastatic
8%
Left ventricular dysfunction
8%
Blood uric acid increased
8%
Myalgia
8%
Pain in extremity
8%
Musculoskeletal pain
8%
Flank pain
8%
Fungal skin infection
8%
Furuncle
8%
Rash
8%
Rash pruritic
8%
Rash papular
8%
Night sweats
8%
Haematuria
8%
Lymphadenopathy
8%
Menometrorrhagia
8%
Deafness unilateral
8%
Pneumothorax
8%
Skin abrasion
8%
Eye pain
8%
Aspartate aminotransferase increased
8%
Blood urine present
100%
80%
60%
40%
20%
0%
Study treatment Arm
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
DS-TB: 2 Months HRZE/ 4 Months HR
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide

Trial Design

4Treatment groups
Experimental Treatment
Group I: Non-hepatically impaired controlsExperimental Treatment1 Intervention
18 matched Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group II: Child-Pugh C (Severe hepatic impairment)Experimental Treatment1 Intervention
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group III: Child-Pugh B (Moderate hepatic impairment)Experimental Treatment1 Intervention
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group IV: Child-Pugh A (Mild hepatic impairment)Experimental Treatment1 Intervention
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PA-824
2010
Completed Phase 3
~1160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,455 Total Patients Enrolled
137 Trials studying Tuberculosis
458,899 Patients Enrolled for Tuberculosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size of this clinical trial?

"Affirmative. Records on clinicaltrials.gov proclaim that this experiment is still looking for participants, with the first posting made on December 11th 2017 and most recent edits occurring in December 1st 2022. 36 patients must be recruited from 2 different medical centres."

Answered by AI

How is PA-824 typically employed in medical practice?

"PA-824 offers a therapeutic approach to tuberculosis, treatment-intolerant pulmonary tb, and other forms of the infections."

Answered by AI

Is enrollment for this trial open at the moment?

"This clinical trial, which was initially advertised on the 11th of December 2017, is still actively recruiting. The details were last updated on 1st December 2022 according to clinicaltrials.gov."

Answered by AI

What can be discerned about the safety of PA-824 from current research?

"Taking into consideration the limited data available, our team has concluded that PA-824 ranks low on the safety scale with a score of 1."

Answered by AI

Have any other clinical trials utilized PA-824 as a therapeutic agent?

"In 2017, the first research into PA-824 was conducted at Duke University School of Medicine's Clinical Research Institute. 18 studies have been successfully completed since then and there are 4 live clinical trials with a majority taking place in Saint Louis, Missouri."

Answered by AI

Are there any restrictions regarding participation in this clinical experiment?

"This trial requires 36 participants, aged between 18 and 70, suffering from tuberculosis. In addition to this age requirement, the following criteria must be met: minimal levels of certain chemistry values; no severe hepatic impairment or cirrhosis; non-childbearing potential (post-menopausal for two years minimum); female patients using acceptable forms of contraception during study duration; male subjects refraining from fathering a child for 3 months after dosing with an appropriate birth control measure. Furthermore, all candidates must provide voluntary written consent prior to any procedures being carried out."

Answered by AI

Is this study recruiting participants who are aged 75 or older?

"This trial is enrolling patients who are of age 18 or older, yet younger than 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pretomanid in Adults With Hepatic Impairment
2017. "Pretomanid in Adults With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02422524.
~2 spots leftby Apr 2025
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