Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381375
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
Drug-drug Interactions With Anti-tuberculous Drugs
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 drugs 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 doesnt include any experimental intervention as its 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 takenor 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 mildself-limiting 2 means moderaterequired treatment 3 severelife-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 symptoms and actions 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
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 drugs 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 doesnt include any experimental intervention as its 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 takenor 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 mildself-limiting 2 means moderaterequired treatment 3 severelife-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 symptoms and actions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None