Drug-drug Interactions With Anti-tuberculous Drugs

NCT06381375 | Recruiting DMC

• 1 other identifier: 24-2-2024
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients.

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (2)

• Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients

  6 months

• 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events).

  6 months

Study Arms (1)

Tuberculous Patients

Other: Anti Tuberculosis Drug

Interventions

Anti Tuberculosis Drug OTHER

1. Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients. 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events).

Tuberculous Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with tuberculosis at the tuberculosis outpatient clinic at Kasr Alainy Faculty of Medicine, Cairo University

You may qualify if:

• All patients diagnosed with tuberculosis and referred to Tuberculosis outpatient clinic, Kasr Alainy Faculty of Medicine, Cairo University, starting after the obtaining of the Scientific/Ethical approval of the study protocol.

You may not qualify if:

• Refusal by the patient/patient's guardian to participate in this study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Omnia Azmy Nabeh

Cairo, 11562, Egypt

RECRUITING

Related Publications (2)

• Ghazy RM, Sallam M, Ashmawy R, Elzorkany AM, Reyad OA, Hamdy NA, Khedr H, Mosallam RA. Catastrophic Costs among Tuberculosis-Affected Households in Egypt: Magnitude, Cost Drivers, and Coping Strategies. Int J Environ Res Public Health. 2023 Feb 1;20(3):2640. doi: 10.3390/ijerph20032640.

  PMID: 36768005 BACKGROUND

• Yew WW. Clinically significant interactions with drugs used in the treatment of tuberculosis. Drug Saf. 2002;25(2):111-33. doi: 10.2165/00002018-200225020-00005.

  PMID: 11888353 BACKGROUND

MeSH Terms

Interventions

Antitubercular Agents

Intervention Hierarchy (Ancestors)

Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Soha Aly Elmorsy

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omnia Azmy Nabeh, MD

CONTACT

01066969673; omnia.azmy@kasralainy.edu.eg

Hoda Mohamed Abdel-Hamid

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 15, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

EG (1)