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Tuberculosis, MDRPhase 3FS-1NCT02607449

FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis

A Phase 3 study testing FS-1 in people with Tuberculosis, MDR, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 6 sites in 2 countries.

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

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis, MDR
What is being tested?
FS-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
6 sitesin 2 countries
Study dates
Dec 2013to Oct 2020
Phase
Phase 3
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

  • Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:
  • MDR Tuberculosis confirmed by microbiology test at screening.
  • resistance to isoniazid and rifampicin demonstrated by drug susceptibility test
  • susceptiblity of TB bacteria to fluoroquinolones and aminoglycoside/capreomycin
  • all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol
  • Willing to freely and voluntarily give signed informed consent
  • Willing and capable to comply with all requirements of the protocol

Who cannot join

  • Pregnancy and breast-feeding;
  • Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
  • Severe mental disorders;
  • Allergy to iodine-containing drugs, hypersensitivity to iodine;
  • Intolerance to second-line drugs;
  • Epidermomycosis
Show all 15Show fewer
  • Socially maladjusted patients suffering from alcoholism and drug addiction;
  • Hypothyroidism;
  • Hashimoto's thyroiditis;
  • TB treatment for more than two months before the start of the study;
  • Not willing to adhere to TB therapy;
  • at the discretion of the researcher, if the continuation of the study is harmful to the patient;
  • side effects related with the study drug
  • patient's decision to stop participation in study
  • appearance of any exclusion criteria during study

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Kazakhstan5 sites

  • West Kazakhstan Marat Ospanov Medical University

    Aktobe, West Kazakhstan, 030019

  • National scientific center of phthisiopulmonology Ministry of health of the Republic of Kazakhstan

    Almaty, 050010

  • Center of Phthisiopulmonology of the Public Health Administration of Almaty

    Almaty, 050030

  • Karaganda Medical University

    Karaganda

  • Semey Medical University

    Semey, East Kazakhstan, 071400

Other trials in Kazakhstan

Kyrgyzstan1 site

  • National Center of Phthisiatry

    Bishkek, 030019

Other trials in Kyrgyzstan

About this study

Official title: Randomized, Placebo-controlled Study of Safety and Therapeutic Efficacy of the Drug FS-1 in the Oral Dosage Form in Drug-resistant Pulmonary Tuberculosis

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to treat drug-resistant forms of this infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).

Read the detailed description

Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter, placebo-controlled (add-on), double-blind and two arms trial.

The study consists of two following phases: treatment phase - 6 months and follow-up phase 12 months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.

All data will be compiled in an Electronic Data Capture System with further statistical analysis according to approved Statistical Analytical Plan.

Being tested
FS-1, Placebo
Keywords
Tuberculosis, Multi-drug resistant TB, TB treatment
Medical subject headings
Tuberculosis, Multidrug-Resistant, Tuberculosis

What participants receive

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

  • FS-1Drug

    FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.

  • PlaceboDrug

    Placebo without any active pharmaceutical ingredients

Study groups in NCT02607449
Study groupRoleWhat they receive
AExperimentalStandard TB treatment+ treatment regiment with FS-1 drug. Study drug was given to the patients orally once per day in dose of 2.5 mg/kg along with other prescribed TB drugs.
Receives: Drug: FS-1
BPlacebo comparatorStandard TB treatment + treatment regiment with a placebo. Instead of study drug the placebo was given to the patients orally once per day along with other prescribed TB drugs (in quntity equal to study drug).
Receives: Drug: Placebo

What is being measured

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

  1. Time to persistently negative sputum cultures

    Time from the start of treatment with study drug to the first negative M. tuberculosis sputum culture on solid medium followed by 4 consecutive negative results with an interval of at least 30 days. Measured in months. Estimated population: randomized subjects who took at least 70% of planned study drug doses; having a positive bacterial culture M. tuberculosis at the baseline; who missed less than 2 consecutive visits or less than 14 consecutive days of study drug treatment (modified ITT analysis).

    Measured: 18 months

  2. Proportion of Patients with persistently negative sputum cultures (SCC)

    Sputum culture conversion (SCC) is a persistently negative result of the sputum culture at one year from the patients who had sputum samples positive for growth of M. tuberculosis at baseline and not followed by any positive culture until the end of the trial. SCC corresponds to the outcome "cured" if at least 5 negative bacteriological cultures is recorded (on solid medium) during 12 months with an interval of at least 30 days.

    Measured: 12 months

Secondary outcomes (7)

  1. The proportion of subjects with relapse of tuberculosis

    Relapse is defined when patient received full study drug treatment course (6 months) and bacteriological culture become again positive after 5 negative bacteriological cultures (on solid medium) during 12 months with an interval of at least 30 days.

    Measured: 12 months

  2. Patients body weight dynamics for the period of 18 months.

    Comparison of subjects' weight, using as the baseline subjects' weight before the start of the treatment with the subjects' weight during the treatment cycle with the study drug (6 months) and during 12 months of follow-up period.

    Measured: 18 months

  3. The median time to occurrence of negative sputum microscopy result

    The average time between positive and negative sputum smear microscopy results during the treatment.

    Measured: 18 months

  4. The time when TB clinical symptoms not observed

    Assessment of period between TB clinical symptoms and their disappearance. Observed of TB clinical symptoms are as follows: chest pain, difficulties to breath, cough, sputum, intoxication symptoms.

    Measured: 18 months

  5. Dynamics of the tuberculosis process based on subjects chest x-ray diagnosis.

    The positive dynamics of the subject X-ray picture of the tuberculous process is characterized by the closure of TB caused cavities, a decrease of lung infiltration, nodular lesions, pleural effusion and lymphadenopathy.

    Measured: 18 months

  6. The incidence and severity of Adverse Events, Serious Adverse Events and drug related Adverse Drug Reactions

    Assessment of Adverse Events and Drug Reactions during the study (6 months of treatment and 12 months of follow-up period).

    Adverse event (AE) is any untoward medical occurrence in subject administered the study drug and that does not necessarily have a causal relationship with this treatment. AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.

    Serious Adverse Event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

    Adverse drug reaction - all noxious and unintended responses to the study drug, when a causal relationship between the study drug and an adverse event is at least a reasonable possibility.

    Measured: 18 months

  7. Assessment of the study drug effect on thyroid gland function

    Assessment of thyroid hormones and antibodies in the blood (free triiodothyronine (FT3), free thyroxine (FT4), total thyroxine (TT4),total triiodothyronine (TT3),thyroid stimulating hormone (TSH), antibodies to thyroglobulin and thyroid peroxidase), and results of ultrasound of the thyroid gland before treatment, during treatment (6 months) and during the follow-up period (12 months).

    Measured: 18 months

Timeline

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

  1. First posted18 Nov 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2020
  4. Study completionOct 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02607449
Sponsor's protocol ID
TP-004 V 5.1
Acronym
FS-1
Status last verified
May 2022
First submitted
11 Nov 2015
Last updated
24 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FS-1 in people with Tuberculosis, MDR, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 6 sites in 2 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 7 inclusion and 15 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Kazakhstan, Kyrgyzstan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Time to persistently negative sputum cultures (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT02607449.

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 24 May 2022.

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