Drug-drug Interactions With Anti-tuberculous Drugs

Drug-drug Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381375
• Other study ID #: 24-2-2024
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Omnia Azmy Nabeh, MD
• Phone: 01066969673
• Email: omnia.azmy[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 15, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-drug Interaction
• Tuberculosis

Intervention

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).

Locations

Country	Name	City	State
Egypt	Omnia Azmy Nabeh	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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