NCT01456845

Brief Summary

The purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of rifampicin and other antituberculosis drugs and compare these drug levels in patients who develop drug induced hepatotoxicity versus those who do not .The study hypothesis is that the ATT drug induced hepatotoxicity is related to free drug levels of rifampicin and other antituberculosis drugs .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

October 20, 2011

Last Update Submit

August 30, 2012

Conditions

HepatitisTuberculosis

Keywords

Plasma levelsisoniazidrifampicinpyrazinamidehepatoxicity

Outcome Measures

Primary Outcomes (1)

  • Evaluation of plasma levels of isoniazid, rifampicin, pyrazinamide among cases and controls

    21 months

Secondary Outcomes (1)

  • Evaluation of plasma drug levels and its correlation among cases and controls and to assess the ability of these drug levels to predict subsequent development of drug induced hepatoxicity

    21 months

Study Arms (1)

2

Cases - those patients who develop DIH while on regular treatment with anti-TB drugs. Controls - patients who do not develop DIH while on regular treatment with anti-TB drugs.

Eligibility Criteria

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

Subjects: Patients with diagnosis of pulmonary/extrapulmonary Tuberculosis attending the out-patient department of the All India Institute of Medical Sciences, New Delhi, will form the study population. Cases - those patients who develop DIH while on regular treatment with anti-TB drugs Controls - patients who do not develop DIH while on regular treatment with anti-TB drugs

You may qualify if:

  • Age: patients in the range between 18 to 65 years
  • Patients of either gender
  • Probable or confirmed cases of TB
  • Patients receiving daily antituberculosis drugs

You may not qualify if:

  • Patients with serological evidence of acute viral hepatitis A, B, C, or E and carriers of HBV and/or HCV
  • HIV positive patients
  • Presence of chronic liver disease or cirrhosis
  • Cognitive dysfunction
  • Terminally sick patients and unlikely to survive for 6-9 months
  • Concomitant administration of other potentially hepatotoxic drugs(Methotrexate, Phenytoin, phenobarbitone, carbamazepine ,valproate Atenolol, labetalol, Salicylates , allopurinol, quinine, quinidine, fluconazole, cimetidine, ethionamide, verapamil, probenecid, TCA, halothane)
  • Chronic alcoholics consuming \>48 g/day for more 1 year
  • Patients not willing to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Related Publications (1)

  • Satyaraddi A, Velpandian T, Sharma SK, Vishnubhatla S, Sharma A, Sirohiwal A, Makharia GK, Sinha S, Biswas A, Singh S. Correlation of plasma anti-tuberculosis drug levels with subsequent development of hepatotoxicity. Int J Tuberc Lung Dis. 2014 Feb;18(2):188-95, i-iii. doi: 10.5588/ijtld.13.0128.

    PMID: 24429311DERIVED

MeSH Terms

Conditions

HepatitisTuberculosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Surendra K Sharma, MD,Ph.D

    All India Institute of Medical Sciences, New Delhi-110029, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 21, 2011

Study Start

August 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

IN(1)