Status:
COMPLETED
Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)
Lead Sponsor:
University of Alberta
Conditions:
Bariatric Surgery
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Bariatric (obesity) surgery has become the preferred treatment option for patients with severe obesity and is increasing in popularity. It is commonly performed, with nearly 350 000 operations in the ...
Detailed Description
In the past decade, bariatric surgery has emerged as the preferred treatment option for patients with either severe obesity \[body mass index (BMI) ≥ 40 kg/m2\] or moderate obesity (BMI 35.0-39.9 kg/m...
Eligibility Criteria
Inclusion
- Male and Female
- 18 - 60 years old
- ≥ 3 months post-RYGB surgery or a suitable control for bariatric surgery
- Able to provide written informed consent.
Exclusion
- Undergone or undergoing reversal of a previous bariatric procedure which involves further resection or bypass of the intestine.
- Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
- Currently on azithromycin therapy
- Any contraindications to azithromycin therapy such as:
- Allergy or hypersensitivity to the drug
- liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
- end-stage renal failure (glomerular filtration rate \< 10 ml/min)
- macrolide hypersensitivity
- history of torsade de pointes or baseline QTc interval ≥ 500 ms
- acute illness
- Pregnant or nursing
- Concomitant treatment with septra, anti-HIV drugs, digoxin, disopyramide, ergotamine, dihydroergotamine, triazolam, antihistamines (terfenadine, astemizole) and theophylline is also a contraindication to enrolment because of the potential for drug interactions that would affect the blood concentrations of azithromycin or these agents.
- Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01154569
Start Date
June 1 2010
End Date
July 1 2011
Last Update
July 29 2011
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7