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Tuberculosis, PulmonaryPhase 2NAC-TBNCT03702738

Adjunctive NAC in Adult Patients With Pulmonary Tuberculosis

A Phase 2 study testing N-acetyl cysteine in people with Tuberculosis, Pulmonary, run by The Aurum Institute NPC at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine if adjunctive N-acetylcysteine 1200 mg twice a day (BID) accelerates sputum culture conversion and normalization of cellular glutathione in tuberculosis (TB), and to assess its potential effects on lung and immune function Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
N-acetyl cysteine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTanzania
Study dates
1 Mar 2019to 31 Dec 2021
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 65 years, male or female
  • Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any trial related procedures.
  • Body weight (in light clothing without shoes) between 40 and 90 kg.
  • First episode of pulmonary tuberculosis
  • Positive sputum AFB smear with subsequent culture confirmation OR positive Xpert TB/RIF with Ct ≤27.1 [3].
  • RIF susceptibility diagnosed by Xpert TB/RIF OR Hain test
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  • Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis [4]
  • If sexually active, willing to use an effective contraceptive method for the duration of tuberculosis treatment
  • HIV-1 seronegative, or if HIV-1 seropositive, CD4 T cell count >220/ul

Who cannot join

  • Any condition for which participation in the trial, as judged by the investigator, could compromise the well being of the subject or prevent, limit or confound protocol specified assessments
  • Current or imminent (within 24 hr) treatment for malaria.
  • Pregnancy
  • Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow up period.
  • TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.
  • History of allergy or hypersensitivity to any of the trial therapies or related substances, including known allergy or suspected hypersensitivity to rifampin.
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  • Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
  • Prior TB treatment in the preceding 6 months.
  • Angina pectoris requiring treatment with nitroglycerin or other nitrates
  • Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
  • Random blood glucose >140 mg/dL, or history of unstable Diabetes Mellitus which required hospitalization for hyper- or hypo-glycaemia within the past year prior to start of screening.
  • Use of systemic corticosteroids within the past 28 days.
  • Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 protease inhibitors
  • Subjects with any of the following abnormal laboratory values:
  • creatinine >2 mg/dL
  • haemoglobin <8 g/dL
  • platelets <100x109 cells/L
  • serum potassium <3.5
  • aspartate aminotransferase (AST) ≥2.0 x ULN
  • alkaline phosphatase (AP) >5.0 x ULN
  • total bilirubin >1.5 mg/dL

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • NIMR-Mbeya Medical Research Centre

    Mbeya

Other trials in Tanzania

About this study

Official title: A Prospective Randomized Controlled Trial of Adjunctive N-acetylcysteine (NAC) in Adult Patients With Pulmonary Tuberculosis: a Sub-study of TB Sequel

To determine if adjunctive N-acetylcysteine 1200 mg twice a day (BID) accelerates sputum culture conversion and normalization of cellular glutathione in tuberculosis (TB), and to assess its potential effects on lung and immune function

Read the detailed description

This is a randomized controlled, 2-arm, parallel group substudy of the TB-SEQUEL cohort study. It will enrol drug sensitive TB patients with moderately advanced or far advanced pulmonary disease by chest X-ray. Patients providing informed consent will undergo screening evaluations to establish eligibility. Patients meeting all the inclusion and none of the exclusion criteria will be randomized to receive standard TB treatment (2HRZE/4HR) plus NAC 1200 mg BID for months 1-4, or standard treatment alone. During the treatment period patients will undergo safety, efficacy, and biomarker assessments at specified time points. After a final evaluation at 6 months, patients will continue follow-up as a part of the main TB-SEQUEL cohort study.

Being tested
N-acetyl cysteine
Keywords
Host-directed therapy, N-acetylcysteine, Glutathione
Medical subject headings
Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-acetyl cysteineDrug

    Also called NAC

    NAC is listed by WHO as an essential medicine for its use in paracetamol (acetaminophen) poisoning, in which it protects against fatal liver injury. It also reduces the viscosity of sputum, thereby serving as an expectorant.

Study groups in NCT03702738
Study groupRoleWhat they receive
NACExperimentalPatients will be randomized to receive standard TB treatment with N-acetylcysteine 1200 mg BID x 4 months, followed by 2 months of standard TB treatment alone
Receives: Drug: N-acetyl cysteine
No NACNo interventionPatients will be randomized to receive 6 months standard TB treatment alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median time to stable sputum culture conversion using liquid medium

    Measured: 6 months

Secondary outcomes (3)

  1. Change from baseline in mean concentration of reduced glutathione (GSH) in blood cells, expressed as the AUC during days 1-28

    Measured: 1-28 days

  2. GSH concentrations and the ratio of GSH to GSSG (oxidized glutathione) measured at discrete time points during treatment

    Measured: 6 months

  3. Whole blood bactericidal activity (WBA) prior and at intervals post dosing

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start1 Mar 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702738
Sponsor's protocol ID
AUR1-1-219
Acronym
NAC-TB
Status last verified
Nov 2024
First submitted
4 Oct 2018
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wallis RS, Sabi I, Lalashowi J, Bakuli A, Mapamba D, Olomi W, Siyame E, Ngaraguza B, Chimbe O, Charalambous S, Rachow A, Ivanova O, Zurba L, Myombe B, Kunambi R, Hoelscher M, Ntinginya N, Churchyard G. Adjunctive N-Acetylcysteine and Lung Function in Pulmonary Tuberculosis. NEJM Evid. 2024 Sep;3(9):EVIDoa2300332. doi: 10.1056/EVIDoa2300332. Epub 2024 Aug 27.

    PubMed 39189858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-acetyl cysteine in people with Tuberculosis, Pulmonary, run by The Aurum Institute NPC at 1 site in Tanzania.

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 9 inclusion and 21 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Median time to stable sputum culture conversion using liquid medium (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702738, which also lists 1 linked publication.

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 12 Nov 2024.

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