Drug-drug Interactions With Anti-tuberculous Drugs

Assessment of the Prevalence and the Outcome of Prescribing Drugs Known to Have Major Drug-Drug Interactions With Anti-tuberculous Drugs Among Kasr Alainy Tuberculous Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Drug-drug Interaction
• Intervention / Treatment: Other: Anti Tuberculosis Drug

Detailed Description

This study is a longitudinal cohort study that will include all the patients diagnosed with tuberculosis who visit the Tuberculous outpatient clinic at Kasr Alainy after obtaining the approval of the ethical committee, and for about 6 months, to include at least 400 patients as estimated from the sample size calculation result.

A detailed history will be taken including: full name, age, sex( maternity history will be taken in case of female patients to report any current pregnancy or lactation) , mobile number, occupation, history of smoking( cigarette or shisha), type of TB, method of TB diagnosis, history of any comorbidities, current drug(s), and the anti-tuberculous therapy regimen ( including name and dose of each drug), in addition to a baseline liver enzymes( ALT, AST) and a complete blood count (CBC) A written consent will be obtained from the patients, however the study doesn't include any experimental intervention, as it's a pure observational study and it possess no more risk than that encountered in routine daily practice. Patients' confidentiality will be respected and protected. Patients' identity will not be put on the data collection form, and will be replaced by a serial number. This serial study number is linked to the patient identity in a document that will be retained inside the department and will not be used outside the hospital.

Patients will be educated and provided with a sheet (titled drug monitoring diary) to document any drugs that are taken/or will be prescribed concomitantly during the anti-tuberculous therapy in the first month after the initial visit. This diary includes: the drug name, date of start, dose (concentration and frequency), and duration of therapy.

Patients will also be educated and provided with a check list sheet (titled adverse drug events diary, as shown in table 3) to record in a day-by day process any possible adverse drug events for one month, and to score the severity of these events from 1 to 3, as 1 means mild/self-limiting, 2 means moderate/required treatment, 3 severe/life-threatening that needed a specialist consultation and management.

Patients will be educated to deal with expected minor adverse drug events, and will be provided with the contact details of the corresponding researcher who will direct each patient to the corresponding physician accordingly, in case of moderate to severe adverse drug events.

A detailed history of the moderate or severe adverse drug event will be recorded by the researchers, including the (date, symptom(s), and action(s) required to manage that event) Patients are instructed routinely to come for a follow up visit after one month. In this visit, laboratory tests (ALT, AST, CBC) are ordered. The research team will record the laboratory results and the drug monitoring and adverse drug diaries notes. The data will be revised for any missing or conflicting data then the sheets will be prepared for analysis

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Omnia Azmy Nabeh, MD; Phone Number: 01066969673; Email: omnia.azmy@kasralainy.edu.eg
• Study Contact Backup: Name: Hoda Mohamed Abdel-Hamid

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Omnia Azmy Nabeh
    • Contact: Omnia Azmy Nabeh, MD; Phone Number: 01066969673; Email: omnia.azmy@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Tuberculous Patients

Other: Anti Tuberculosis Drug; Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Soha Aly Elmorsy, Cairo university

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Anti-Infective Agents; Anti-Bacterial Agents; Antitubercular Agents
• Other Study ID Numbers: 24-2-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No