Bariatric SurgeryAbsorb-AzithroNCT01154569
Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)
A study testing Azithromycin in people with Bariatric Surgery, run by University of Alberta at 1 site in Canada.
Trial 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 world every year. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 world every year. The most common type of bariatric surgery is gastric bypass, in which stomach size is reduced by 95% and the upper intestine is bypassed. Bypass of the upper intestine may lead to medication malabsorption, although this potential adverse effect has received little study.
The objective of this study is to determine whether gastric bypass reduces the absorption of a azithromycin, a medication commonly prescribed first-line for infections, especially pneumonia. Patients and non-surgical controls will receive a single dose of azithromycin under highly standardized study conditions. The absorption of azithromycin will be calculated and compared between surgical and non-surgical study groups.
The investigators hypothesis is that there will be a significant reduction in the absorption of azithromycin in gastric bypass patients compared to non-surgical controls. This raises the possibility that post-gastric bypass patients treated with azithromycin may fail to respond to treatment, become worse and even die. This study will have important implications for the large number of past and future gastric bypass recipients.
Read 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/m2) and a major medical complication (e.g., diabetes, hypertension, sleep apnea). Surgery reduces weight by 33% after 2-3 years, and is associated with improvements in obesity-related comorbidities, mortality and quality of life.
Consequently, demand for bariatric surgery is increasing at an exponential rate in Canada, the United States and globally, with 350 000 estimated surgeries performed annually globally. Laparoscopic Roux-en-Y gastric bypass is the most commonly performed type of bariatric procedure. This operation restricts stomach capacity 5% of its original size and bypasses the duodenum and much of the jejunum. The major adverse consequence of intestinal bypass is nutrient malabsorption leading to deficiencies of iron, fat-soluble vitamins and vitamin B12. The malabsorption of drugs, many of which are designed to be maximally absorbed in the upper small intestine, is also a major potential concern. Surprisingly, this issue has received surprisingly little attention in the published literature. A number of factors may contributed to reduced absorption post-bypass, delayed gastric emptying, reduced intestinal transit time, diminished opportunity for mucosal exposure, and changes in drug solubility resulting from alterations in intestinal pH.
Azithromycin, a macrolide antibiotic that interferes with ribosomal protein synthesis, is indicated for the treatment of respiratory tract, skin/soft tissue, sinus and pelvic infections. Azithromycin is most commonly prescribed orally for the treatment of community-acquired pneumonia (CAP), and is recommended as first-line treatment in patients with this condition who are being managed on an outpatient basis. CAP accounts for over 1 million physician visits, 60 000 hospital admissions, 640 000 days of restricted activity and (together with influenza) is the 6th leading cause of death in the United States. In Edmonton, at least 50% of CAP is managed as with outpatient therapy. Post-bariatric surgery patients who develop CAP and are treated with outpatient oral antibiotics would clearly be at risk of treatment failure if the antibiotic is not optimally absorbed. Treatment failure may pose a significant risk of respiratory complications or death. Unfortunately, no studies have examined the absorption of antibiotics post-gastric bypass. Because, azithromycin is intrinsically poorly absorbed, with a bioavailability of only 38%, suboptimal absorption post-gastric bypass is a major concern. The purpose of this study is to determine whether gastric bypass results in clinically significant reductions in azithromycin absorption.
- Conditions
- Bariatric Surgery
- Being tested
- Azithromycin
- Keywords
- drug absorption, azithromycin, obesity, bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
500 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Post Roux-en-Y gastric bypass | Active comparator | Post-bypass receiving a single dose of azithromycin Receives: Drug: Azithromycin |
| Controls | Active comparator | BMI and sex matched. Have not undergone surgery Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Azithromycin absorption
Area-under-the-curve azithromycin absorption from 0 to 24 hours post dose.
Measured: Blood samples for analysis of azithromycin levels collected at 0, 0.5, 1, 1.5, 2, 3, 5, 7 and 24 hours post-dose.
Secondary outcomes (2)
Tmax
Time to peak concentration
Measured: instant
Cmax
Maximal concentration post-ingestion of azithromycin
Measured: instant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Raj Padwal, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154569
- Sponsor's protocol ID
- 0002390
- Acronym
- Absorb-Azithro
- Status last verified
- Jul 2011
- First submitted
- 21 Jun 2010
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)
- ClinicalTrials.gov ID
- NCT01154569
- Acronym / sponsor ID
- Absorb-Azithro / 0002390
- Conditions
- Bariatric Surgery
- Keywords
- drug absorption, azithromycin, obesity, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 world every year. The most common type of bariatric surgery is gastric bypass, in which stomach size is reduced by 95% and the upper intestine is bypassed. Bypass of the upper intestine may lead to medication malabsorption, although this potential adverse effect has received little study.
The objective of this study is to determine whether gastric bypass reduces the absorption of a azithromycin, a medication commonly prescribed first-line for infections, especially pneumonia. Patients and non-surgical controls will receive a single dose of azithromycin under highly standardized study conditions. The absorption of azithromycin will be calculated and compared between surgical and non-surgical study groups.
The investigators hypothesis is that there will be a significant reduction in the absorption of azithromycin in gastric bypass patients compared to non-surgical controls. This raises the possibility that post-gastric bypass patients treated with azithromycin may fail to respond to treatment, become worse and even die. This study will have important implications for the large number of past and future gastric bypass recipients.
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/m2) and a major medical complication (e.g., diabetes, hypertension, sleep apnea). Surgery reduces weight by 33% after 2-3 years, and is associated with improvements in obesity-related comorbidities, mortality and quality of life.
Consequently, demand for bariatric surgery is increasing at an exponential rate in Canada, the United States and globally, with 350 000 estimated surgeries performed annually globally. Laparoscopic Roux-en-Y gastric bypass is the most commonly performed type of bariatric procedure. This operation restricts stomach capacity 5% of its original size and bypasses the duodenum and much of the jejunum. The major adverse consequence of intestinal bypass is nutrient malabsorption leading to deficiencies of iron, fat-soluble vitamins and vitamin B12. The malabsorption of drugs, many of which are designed to be maximally absorbed in the upper small intestine, is also a major potential concern. Surprisingly, this issue has received surprisingly little attention in the published literature. A number of factors may contributed to reduced absorption post-bypass, delayed gastric emptying, reduced intestinal transit time, diminished opportunity for mucosal exposure, and changes in drug solubility resulting from alterations in intestinal pH.
Azithromycin, a macrolide antibiotic that interferes with ribosomal protein synthesis, is indicated for the treatment of respiratory tract, skin/soft tissue, sinus and pelvic infections. Azithromycin is most commonly prescribed orally for the treatment of community-acquired pneumonia (CAP), and is recommended as first-line treatment in patients with this condition who are being managed on an outpatient basis. CAP accounts for over 1 million physician visits, 60 000 hospital admissions, 640 000 days of restricted activity and (together with influenza) is the 6th leading cause of death in the United States. In Edmonton, at least 50% of CAP is managed as with outpatient therapy. Post-bariatric surgery patients who develop CAP and are treated with outpatient oral antibiotics would clearly be at risk of treatment failure if the antibiotic is not optimally absorbed. Treatment failure may pose a significant risk of respiratory complications or death. Unfortunately, no studies have examined the absorption of antibiotics post-gastric bypass. Because, azithromycin is intrinsically poorly absorbed, with a bioavailability of only 38%, suboptimal absorption post-gastric bypass is a major concern. The purpose of this study is to determine whether gastric bypass results in clinically significant reductions in azithromycin absorption.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post Roux-en-Y gastric bypass | Active comparator | Drug: AzithromycinPost-bypass receiving a single dose of azithromycin |
| Controls | Active comparator | Drug: AzithromycinBMI and sex matched. Have not undergone surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: Zithromax500 mg single dose | Drug | Controls, Post Roux-en-Y gastric bypass |
Primary outcome
Azithromycin absorption
Time frame: Blood samples for analysis of azithromycin levels collected at 0, 0.5, 1, 1.5, 2, 3, 5, 7 and 24 hours post-dose.
Area-under-the-curve azithromycin absorption from 0 to 24 hours post dose.
2 secondary outcomes
Tmax
Time frame: instant
Cmax
Time frame: instant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Padwal, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin in people with Bariatric Surgery, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Azithromycin absorption (time frame: Blood samples for analysis of azithromycin levels collected at 0, 0.5, 1, 1.5, 2, 3, 5, 7 and 24 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.