Disease Due to Gram-positive BacteriaPhase 1RMC-11NCT02391077
A Trial Assessing Efficacy of Various Antimicrobial Techniques for Reducing Bacterial Load
A Phase 1 study testing Povidone-Iodine, Antibiotic topical cream and Chlorhexidine 1% in people with Disease Due to Gram-positive Bacteria, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial summary
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential. Read more about this study
- Who is it for?
- Ages 21 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disease Due to Gram-positive Bacteria
- What is being tested?
- Povidone-Iodine, Antibiotic topical cream and Chlorhexidine 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteRwanda
- Study dates
- Apr 2015to Jul 2015
- Phase
- Phase 1
- 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 21 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- Able to understand the study procedures and requirements
- Agrees to participate in either arm and to follow the hygiene and wound care instructions
- Agrees to have swab samples
Show all 11Show fewer
- Agrees to abstain sexual intercourse for 6 weeks post device removal
- Agrees to abstain from masturbation for 2 weeks post device removal
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision
- Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- Subject agrees to anonymous video and photographs of the procedure and follow up visits.
Who cannot join
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes, by questionnaire
- Known allergy to Betadin-Iodine
- Known allergy to antibiotics containing Bacitracin, Neomycin and Polymixin
- Subject who have an abnormal penile anatomy or any penile diseases
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
Trial locations and contacts
1 site in 1 country.
Rwanda1 site
Kanombe Military Hospital
Kigali, Kigali, 3377
Leon Muyenzi Ngeruka, M.D., +250 788501063, dr_ngemleon@yahoo.com
Jean-Paul Bitega, M.D.
About this study
Official title: A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
Read the detailed description
The PrePex device was accepted for the World Health Organization (WHO) list of prequalified male circumcision (MC) devices and was listed on 31 May 2013.
PrePex became the first medical device for adult male circumcision to receive WHO prequalification as an alternative to the conventional surgical circumcision methods already recognized by WHO.
Voluntary Medical Male Circumcision (VMMC) is a one-time, low cost intervention that shown to reduce men's risk of HIV infection by approximately 70 percent. The WHO recommends VMMC as part of a comprehensive package of HIV prevention services.
The PrePex compresses the foreskin causing ischemic necrosis. Due to the foreskin necrotic state, it is no longer possible for men to fully retract the skin and properly clean the sulcus and inner foreskin, the sub-preputial space normally has a low oxygen environment facilitating anaerobe growth, and following device placement the environment becomes more so leading to a higher bacterial load. This was suggested by reports of unpleasant odor following device placement and confirmed by laboratory test done by RHSP Uganda of swabs taken from inside the foreskin prior to device removal, results not yet published.
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
This trial aims to validate the actions needed to minimize the probability of aerobic and anaerobic bacteria overgrowth once PrePex is introduced, and establish a safer procedure.
The trial encompasses different safe and known techniques, such as usage of anti-bacterial topical ointment, its objectives will be evaluated using laboratory tests.
- Conditions
- Disease Due to Gram-positive Bacteria
- Being tested
- Povidone-Iodine, Antibiotic topical cream, Chlorhexidine 1%
- Keywords
- PrePex, Male Circumcision, Bacterial Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineOther
Foreskin disinfection with Povidone-Iodine
Antibiotic topical creamOther
Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
Chlorhexidine 1%Other
Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Standard PrePex Procedure |
| Arm 1 - Maximal intervention | Experimental | 1. Foreskin disinfection with Povidone-Iodine
2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
3. Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days Receives: Other: Povidone-Iodine; Other: Antibiotic topical cream; Other: Chlorhexidine 1% |
| Arm 2 - Medium intervention | Experimental | 1. Foreskin disinfection with Povidone-Iodine
2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus Receives: Other: Povidone-Iodine; Other: Antibiotic topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The semi quantitative count of bacteria on days 0 and 7
Measured: Days 0 and 7
Secondary outcomes (1)
Placement preparation technique as a measure of reduction of preputial space bacterial load
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Due to Gram-positive BacteriaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent Mutabazi, Ministry of Health, Rwanda
- Investigators
- Vincent Mutabazi, M.D., Principal investigator, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391077
- Sponsor's protocol ID
- RMC-11
- Acronym
- RMC-11
- Status last verified
- Mar 2015
- First submitted
- 15 Feb 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two Phase Trial, to Assess Various Antimicrobial Techniques for Reducing Bacterial Load Prior PrePex Removal
- ClinicalTrials.gov ID
- NCT02391077
- Acronym / sponsor ID
- RMC-11 / RMC-11
- Conditions
- Disease Due to Gram-positive Bacteria
- Keywords
- PrePex, Male Circumcision, Bacterial Load
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 18 Mar 2015 (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.
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
Detailed description
The PrePex device was accepted for the World Health Organization (WHO) list of prequalified male circumcision (MC) devices and was listed on 31 May 2013.
PrePex became the first medical device for adult male circumcision to receive WHO prequalification as an alternative to the conventional surgical circumcision methods already recognized by WHO.
Voluntary Medical Male Circumcision (VMMC) is a one-time, low cost intervention that shown to reduce men's risk of HIV infection by approximately 70 percent. The WHO recommends VMMC as part of a comprehensive package of HIV prevention services.
The PrePex compresses the foreskin causing ischemic necrosis. Due to the foreskin necrotic state, it is no longer possible for men to fully retract the skin and properly clean the sulcus and inner foreskin, the sub-preputial space normally has a low oxygen environment facilitating anaerobe growth, and following device placement the environment becomes more so leading to a higher bacterial load. This was suggested by reports of unpleasant odor following device placement and confirmed by laboratory test done by RHSP Uganda of swabs taken from inside the foreskin prior to device removal, results not yet published.
There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space, therefore we would like to investigate possible techniques to reduce this potential.
This trial aims to validate the actions needed to minimize the probability of aerobic and anaerobic bacteria overgrowth once PrePex is introduced, and establish a safer procedure.
The trial encompasses different safe and known techniques, such as usage of anti-bacterial topical ointment, its objectives will be evaluated using laboratory tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard PrePex Procedure |
| Arm 1 - Maximal intervention | Experimental | Other: Povidone-Iodine, Other: Antibiotic topical cream, Other: Chlorhexidine 1%1. Foreskin disinfection with Povidone-Iodine 2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus 3. Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days |
| Arm 2 - Medium intervention | Experimental | Other: Povidone-Iodine, Other: Antibiotic topical cream1. Foreskin disinfection with Povidone-Iodine 2. Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- Able to understand the study procedures and requirements
- Agrees to participate in either arm and to follow the hygiene and wound care instructions
Key exclusion criteria (8 listed)
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes, by questionnaire
- Known allergy to Betadin-Iodine
- Known allergy to antibiotics containing Bacitracin, Neomycin and Polymixin
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 |
|---|---|---|
| Povidone-IodineForeskin disinfection with Povidone-Iodine | Other | Arm 1 - Maximal intervention, Arm 2 - Medium intervention |
| Antibiotic topical creamApplication of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus | Other | Arm 1 - Maximal intervention, Arm 2 - Medium intervention |
| Chlorhexidine 1%Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days | Other | Arm 1 - Maximal intervention |
Primary outcome
The semi quantitative count of bacteria on days 0 and 7
Time frame: Days 0 and 7
1 secondary outcome
Placement preparation technique as a measure of reduction of preputial space bacterial load
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Rwanda Biomedical CentreLink provided by the sponsor.
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.
Vincent Mutabazi, M.D. principal investigator
Ministry of Health, Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povidone-Iodine, Antibiotic topical cream and Chlorhexidine 1% in people with Disease Due to Gram-positive Bacteria, run by Ministry of Health, Rwanda at 1 site in Rwanda.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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 Rwanda. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Mutabazi, M.D. (250788410827, mutabazivincent@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The semi quantitative count of bacteria on days 0 and 7 (time frame: Days 0 and 7). 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 18 Mar 2015.