NCT05359315

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for intramuscular or subcutaneous administration of 500,000 IU.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 1, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 22, 2022

Last Update Submit

May 31, 2022

Conditions

Pulmonary Tuberculosis

Keywords

treatment of drug-resistant pulmonary tuberculosisinterferon gammadrug resistant

Outcome Measures

Primary Outcomes (24)

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    1 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    1 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    2 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    2 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    3 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    3 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    4 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    4 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    5 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    5 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Percentage of patients.

    6 months

  • Sputum smear conversion according to microscopy.

    Sputum smear conversion according to microscopy. Mean time to clinical response.

    6 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    1 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    1 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    2 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    2 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    3 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    3 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    4 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    4 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    5 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    5 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Percentage of patients.

    6 months

  • Sputum smear conversion by culture.

    Sputum smear conversion by culture. Mean time to clinical response.

    6 months

Secondary Outcomes (10)

  • The effectiveness of therapy according to X-ray examination of the chest.

    2 months

  • The effectiveness of therapy according to X-ray examination of the chest.

    4 months

  • The effectiveness of therapy according to X-ray examination of the chest.

    6 months

  • The effectiveness of therapy according to computed tomography of the chest.

    6 months

  • The effectiveness of therapy according to clinical examination.

    2 months

  • +5 more secondary outcomes

Study Arms (2)

Experimental

Ingaron + basic TB therapy 500,000 IU once daily for 3 months followed by 3 months follow-up

Drug: Interferon-Gamma

No Intervention

only basic anti-tuberculosis therapy

Interventions

Interferon-GammaDRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Also known as: Ingaron, Interferon gamma human recombinant
Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with drug-resistant pulmonary tuberculosis with bacterial excretion

You may qualify if:

  • Men or non-pregnant women 18-75 years of age.
  • For women of childbearing age who are fertile: Agree to completely abstain from sexual intercourse or use dual methods of contraception to prevent pregnancy while participating in the study.
  • Verified diagnosis of pulmonary tuberculosis (infiltrative tuberculosis, fibrous-cavernous tuberculosis in the infiltration phase).
  • A positive sputum smear microscopy test result for acid-fast bacterium, assessed as moderate (++) or massive bacterial excretion (+++) no earlier than 30 days prior to enrollment in the study.
  • Established resistance of the isolated pathogen to at least rifampicin, determined by molecular genetic or cultural methods for determining drug susceptibility.
  • Prescribing the current baseline chemotherapy regimen according to clinical guidelines no earlier than 14 days prior to enrollment in the study.
  • Compliance with prescribed therapy.
  • No concomitant immunotherapy, or 6 months from the last dose of an immunomodulatory drug to the start of therapy.
  • Absence of comorbidities and therapy that may affect the interpretation of study results, in the opinion of the investigator.
  • Signed written informed consent to participate in the study.
  • Willingness and ability to follow protocol requirements throughout the study.

You may not qualify if:

  • For women: pregnant, breastfeeding or planning a pregnancy during the study period.
  • Caseous pneumonia.
  • Asthma, with the exception of mild intermittent asthma.
  • Systemic fungal infections.
  • Use of any investigational drug within 30 days prior to screening.
  • Oncological diseases (cytotoxic chemotherapy, current or received within the last 3 months before the start of treatment).
  • Chronic diseases of the liver or kidneys (an increase in liver transaminases more than 5 times the upper limit of laboratory norms for these indicators; an increase in creatinine above 2 mg / 100 ml (or μmol / l)).
  • Diabetes.
  • HIV infection or other immunodeficiency conditions.
  • Inability, in the opinion of the investigator, to comply with the treatment regimen and the requirements of the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSBI "NMIC FPI" of the Ministry of Health of Russia

Moscow, 127473, Russia

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Anatoly I Saulin, Master

    SPP Pharmaclon Ltd.

    STUDY DIRECTOR

Central Study Contacts

Julia A Isakova, Master

CONTACT

8 107 905 535-33-11isakova@pharmaclon.ru

Polina I Pekhtereva, Master

CONTACT

8 107 909 675-96-43pekhtereva@pharmaclon.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 3, 2022

Study Start

April 15, 2022

Primary Completion

August 1, 2022

Study Completion

May 1, 2023

Last Updated

June 1, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)