HypospadiasPROPHYNCT02096159
Prophylactic Antibiotics or Placebo After Hypospadias Repair
A study testing trimethoprim-sulfamethoxazole in people with Hypospadias, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in 2 countries.
Trial summary
The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial. Read more about this study
- Who is it for?
- Ages Up to 5 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- trimethoprim-sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- mid-to-distal shaft hypospadias
- single-stage hypospadias repair
- length of urethral repair (urethroplasty) less than or equal to 20 mm
- placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively
Who cannot join
- previous hypospadias repair
- prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
- cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
- any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease)
- use of antibiotics within seven days prior to hypospadias repair
- foreskin reconstruction at the time of hypospadias repair
- prescription of oral antibiotics other than Study Medication at the time of hypospadias repair
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.
Read the detailed description
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
- Conditions
- Hypospadias
- Being tested
- trimethoprim-sulfamethoxazole, placebo
- Keywords
- Hypospadias, Anti-Bacterial Agents
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimethoprim-sulfamethoxazoleDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days Receives: Drug: trimethoprim-sulfamethoxazole |
| Placebo | Placebo comparator | placebo oral suspension, 0.5 mL/kg twice daily for 10 days Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infection
Urinary tract infection; cellulitis/wound infection
Measured: up to 30 days
wound-healing complications
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
Measured: up to 5 years
Secondary outcomes (2)
adverse drug reaction
Measured: up to 14 days
C. difficile colitis
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2018
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Earl Y Cheng, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoMark A Faasse, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096159
- Sponsor's protocol ID
- LC/Uro-MF-01
- Acronym
- PROPHY
- Status last verified
- Nov 2024
- First submitted
- 21 Mar 2014
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.
PubMed 35144885
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT02096159
- Acronym / sponsor ID
- PROPHY / LC/Uro-MF-01
- Conditions
- Hypospadias
- Keywords
- Hypospadias, Anti-Bacterial Agents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 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 primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.
Detailed description
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: trimethoprim-sulfamethoxazoletrimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days |
| Placebo | Placebo comparator | Other: placeboplacebo oral suspension, 0.5 mL/kg twice daily for 10 days |
Who may qualify
- Ages
- Up to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- mid-to-distal shaft hypospadias
- single-stage hypospadias repair
- length of urethral repair (urethroplasty) less than or equal to 20 mm
- placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively
Key exclusion criteria (7 listed)
- previous hypospadias repair
- prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
- cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
- any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease)
- use of antibiotics within seven days prior to hypospadias repair
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 |
|---|---|---|
| trimethoprim-sulfamethoxazole | Drug | Antibiotics |
| placebo | Other | Placebo |
Primary outcome
postoperative infection
Time frame: up to 30 days
Urinary tract infection; cellulitis/wound infection
wound-healing complications
Time frame: up to 5 years
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
2 secondary outcomes
adverse drug reaction
Time frame: up to 14 days
C. difficile colitis
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 35144885Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.
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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.
Earl Y Cheng, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Mark A Faasse, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trimethoprim-sulfamethoxazole in people with Hypospadias, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in 2 countries.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
postoperative infection (time frame: up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096159, which also lists 1 linked publication.
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 14 Nov 2024.