An interventional study of trimethoprim-sulfamethoxazole and placebo in Hypospadias, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Active, not recruiting at 2 sites in 2 countries. Open to male participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Prevention
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.
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.
131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's enrollment of 93 is above the median of 68 across 102 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days
Drug: trimethoprim-sulfamethoxazole
placebo oral suspension, 0.5 mL/kg twice daily for 10 days
Other: placebo
postoperative infection
Urinary tract infection; cellulitis/wound infection
Time frame: up to 30 days
wound-healing complications
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
Time frame: up to 5 years
adverse drug reaction
Time frame: up to 14 days
C. difficile colitis
Time frame: up to 6 months
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago