NCT03692715 (APPEAL) is a Phase 4 clinical trial of Ciprofloxacin in Ureteral Stones, sponsored by Clinical Urology and Epidemiology Working Group.

Who is sponsoring NCT03692715?

NCT03692715 is sponsored by Clinical Urology and Epidemiology Working Group.

What drugs are being tested in NCT03692715?

Interventions in NCT03692715: Ciprofloxacin, Placebo.

What condition does NCT03692715 study?

NCT03692715 studies Ureteral Stones, Ureteral Calculi, Nephrolithiasis.

Is NCT03692715 still recruiting?

NCT03692715 is currently completed. Last updated 28 March 2025.

Last reviewed 2025-03-28 · How we verify

NCT03692715: APPEAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Completed Phase 4 Last updated 28 March 2025

What this trial tests

Phase 4 trial testing Ciprofloxacin in Ureteral Stones in 1,732 participants. Completed in 31 December 2024.

Timeline

27 September 2018

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Clinical Urology and Epidemiology Working Group
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,732
Start date	27 September 2018
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	10 locations across Finland, Russia, Saudi Arabia, Ireland, Indonesia, Canada, Switzerland, Iran

Drugs / interventions tested

Ciprofloxacin (Ciprofloxacin) — full drug profile →
Placebo

Conditions studied

Ureteral Stones — all drugs for Ureteral Stones →
Ureteral Calculi — all drugs for Ureteral Calculi →
Nephrolithiasis — all drugs for Nephrolithiasis →

Sponsor

Clinical Urology and Epidemiology Working Group

Who can join

18 and older, any sex, with Ureteral Stones or Ureteral Calculi. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The Saudi urological association guidelines on urolithiasis.
Kamal W, Azhar RA, Hamri SB, Alathal AH, et al · · 2024 · cited 2× · PMID 38415236 · DOI 10.4103/ua.ua_120_23
A Multicentre Randomised Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy in Reducing Urinary Tract Infection (APPEAL): Statistical Analysis Plan and Methodology
Violette PD, Tondro Anamag F, Parpia S, Tornberg SV, et al · · 2025 · cited 1× · DOI 10.1101/2025.03.09.25323609
Northeastern Section of the American Urological Association 73rd Annual Meeting Abstracts.
· 2021 · PMID 34550874 · DOI 10.5489/cuaj.7599

Verify or expand the search:

Other trials of Ciprofloxacin

Trials testing the same drug.

NCT07492134 — APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) · Phase 2 · not yet recruiting
NCT07016165 — Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Maligna · Phase 4 · recruiting
NCT04791579 — Antibiotic Prophylaxis for Neurogenic Bladder Botox · Phase 2 · recruiting
NCT05846399 — CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) · Phase 4 · recruiting
NCT05844735 — A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 · Phase 1 · completed

Other Clinical Urology and Epidemiology Working Group trials

Trials by the same sponsor.

NCT06523959 — Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial · Phase 4 · recruiting
NCT04978259 — SOLIDARITY Finland Long-COVID (Remdesivir Long-term Follow-up Study of COVID Patients) · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03692715 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clinical Urology and Epidemiology Working Group
Last refreshed: 28 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03692715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing