InfectionPhase 4POWARNCT02089568
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation
A Phase 4 study testing Co-Amoxiclav and Normal Saline in people with Infection, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Co-Amoxiclav and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Aug 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
- Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
- Women of child-bearing age taking adequate contraception will be included.
Who cannot join
- Patients with a known allergy to penicillin or other antibiotics.
- Patients with MRSA colonisation.
- Participation in another investigational study within the previous 90 days.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.
Read the detailed description
Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs
- Conditions
- Infection
- Being tested
- Co-Amoxiclav, Normal Saline
- Keywords
- Living donation, Antibiotics, Laparoscopic surgery
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-AmoxiclavDrug
Also called Augmentin
Will receive 1.2g co-amoxiclav at induction
Normal SalineDrug
Placebo - 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Drug: co-amoxiclav | Experimental | experimental Receives: Drug: Co-Amoxiclav |
| Control | Placebo comparator | comparator Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of infection after surgery
Measured: 24 months
Secondary outcomes (7)
Ultrasonic evidence of wound healing
Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.
Measured: 24 months
Length of hospital stay
Measured: 24 months
Readmission rates
Measured: 24 months
Antibiotic associated side effects
Including diarrhoea and allergic reactions
Measured: 24 months
Return to work and normal activities
Measured: 24 months
Quality of life
Measured: 24 months
Relative costs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJul 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Nizam Mamode, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089568
- Sponsor's protocol ID
- POWAR
- Other IDs
- 2012-000942-36
- Acronym
- POWAR
- Status last verified
- Aug 2016
- First submitted
- 14 Mar 2014
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02089568
- Acronym / sponsor ID
- POWAR / POWAR
- Conditions
- Infection
- Keywords
- Living donation, Antibiotics, Laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Mar 2014 (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.
The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.
Detailed description
Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: co-amoxiclav | Experimental | Drug: Co-Amoxiclavexperimental |
| Control | Placebo comparator | Drug: Normal Salinecomparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
- Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
- Women of child-bearing age taking adequate contraception will be included.
Key exclusion criteria (4 listed)
- Patients with a known allergy to penicillin or other antibiotics.
- Patients with MRSA colonisation.
- Participation in another investigational study within the previous 90 days.
- Pregnant or breast-feeding women.
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 |
|---|---|---|
| Co-AmoxiclavAlso: AugmentinWill receive 1.2g co-amoxiclav at induction | Drug | Drug: co-amoxiclav |
| Normal SalinePlacebo - 0.9% saline | Drug | Control |
Primary outcome
Rate of infection after surgery
Time frame: 24 months
7 secondary outcomes
Ultrasonic evidence of wound healing
Time frame: 24 months
Length of hospital stay
Time frame: 24 months
Readmission rates
Time frame: 24 months
Antibiotic associated side effects
Time frame: 24 months
Return to work and normal activities
Time frame: 24 months
Quality of life
Time frame: 24 months
Relative costs
Time frame: 24 months
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 19 Aug 2016.
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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.
Nizam Mamode principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Co-Amoxiclav and Normal Saline in people with Infection, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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 19 Aug 2016. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of infection after surgery (time frame: 24 months). 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 19 Aug 2016.