NCT03416309

Brief Summary

The aim of the study is to investigate the possible correlation of plasma drug concentrations with Time To Positivity (TTP) in liquid culture in patients with active pulmonary multi sensitive TB in the first two weeks of treatment. Secondary aims are: the correlation between plasma drug concentrations and hepato/neuro toxicity; the impact of different allelic variants on PK data, toxicity and TTP in liquid culture; the feasibility of using dried blood/plasma spots to measure plasma concentrations of anti-TB drugs and determine genetic polymorphisms.

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
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

January 10, 2018

Last Update Submit

April 16, 2019

Conditions

Tuberculosis, Pulmonary

Keywords

pharmacokineticspharmacogeneticsTime To Positivity

Outcome Measures

Primary Outcomes (2)

  • Correlation between AUC of RHZE and TTP

    Investigate the correlation of plasma drug concentrations (Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, HRZE) with the change in Time To Positivity (TTP) in liquid culture in patients with active pulmonary TB between the baseline and the first week of treatment.

    1 week from start of treatment

  • Correlation between AUC of RHZE and TTP

    Investigate the correlation of plasma drug concentrations (Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, HRZE) with the change in Time To Positivity (TTP) in liquid culture in patients with active pulmonary TB between the baseline and the second week of treatment.

    2 weeks from start of treatment

Secondary Outcomes (5)

  • Correlation between AUC of RHZE and toxicity

    1 week and 2 weeks from start of treatment

  • Correlation between PG and AUC of RHZE

    1 week and 2 weeks from start of treatment

  • Assess the consistency of results using of DPS for measuring the plasma drug concentrations

    1 week and 2 weeks from start of treatment

  • Correlate AUC of RHZE with antiTB response

    6 months after end of treatment

  • Correlate PG with antiTB response

    6 months after end of treatment

Eligibility Criteria

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

Patients diagnosed with pulmonary TB referred from other primary health centers All the patients with diagnosis of pulmonary DS (drug sensitive) TB will be enrolled. The patients will received standard antitubercular drugs according to international guidelines (RIF 10 mg/kg, INH 5 mg/kg maximum dose 300 mg, ETB 15-20 mg/kg, PZA 25 mg/kg maximum dose 2000 mg) in fasten condition, once daily.

You may qualify if:

  • signed informed consent
  • age \>=18 years;
  • pulmonary tuberculosis defined by positive sputum microscopy (waiting for culture confirmation)
  • sensitivity to first-line anti-TB drugs;
  • normal liver and renal function.

You may not qualify if:

  • severe malnutrition;
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Amedeo di Savoia

Torino, 10149, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples will be stored in an appropriate place recognizable by inscriptions or encodings that will in any way be attributable to any personal or sensitive data of the patient in full respect of privacy, and will be accessible only by the staff involved in the study in full compliance with the safety standards.

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ilaria Motta, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Motta

CONTACT

+390114393856ilaria.motta@unito.it

Andrea Calcagno

CONTACT

+390114393856andrea.calcagno@unito.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 31, 2018

Study Start

May 25, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2022

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

IT(1)