Trial · NCT00761462

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

NCT00761462, Phase 3, Completed, Bayer; results first posted 2009-04-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BAY 0 9867 Cipro Pediatric Use Study (QUIP). Trials, record NCT00761462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761462

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BAY 0 9867 Cipro Pediatric Use Study (QUIP)
NCT number: NCT00761462
Status: Completed
Phases: Phase 3
Enrollment: 1,029 participants, actual
Lead sponsor: Bayer
Conditions: Infectious Diseases
Interventions: Ciprofloxacin, Non-quinolone antibiotic
First posted: 2008-09-29
Last updated: 2015-07-31
Other registries' IDs: eudract:2014-004622-18
Results first posted: 2009-04-14
Limitations and caveats: The study was not randomized or blinded; the demographic and baseline infection characteristics were not comparable for the treatment groups; the long term followup times were different for the two groups (5 year versus 2 years).

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Arthropathy (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Primary	Incidence of Nervous System Events (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Arthropathy (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Patients valid for safety (all patients confirmed to have received at least one dose of study drug)	participants	NUMBER
PRIMARY	Incidence of Nervous System Events (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Patients valid for safety (all patients confirmed to have received at least one dose of study drug).	participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Arthropathy (Cumulative)	Ciprofloxacin	4-6 weeks after treatment	39	participants
Incidence of Arthropathy (Cumulative)	Non-quinolone Antibiotic	4-6 weeks after treatment	9	participants
Incidence of Arthropathy (Cumulative)	Ciprofloxacin	1 year after treatment	64	participants
Incidence of Arthropathy (Cumulative)	Non-quinolone Antibiotic	1 year after treatment	16	participants
Incidence of Arthropathy (Cumulative)	Ciprofloxacin	2 or 5 years after treatment	112	participants
Incidence of Arthropathy (Cumulative)	Non-quinolone Antibiotic	2 or 5 years after treatment	20	participants
Incidence of Nervous System Events (Cumulative)	Ciprofloxacin	4-6 weeks after treatment	38	participants
Incidence of Nervous System Events (Cumulative)	Non-quinolone Antibiotic	4-6 weeks after treatment	10	participants
Incidence of Nervous System Events (Cumulative)	Ciprofloxacin	1 year after treatment	49	participants
Incidence of Nervous System Events (Cumulative)	Non-quinolone Antibiotic	1 year after treatment	13	participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment	STARTED	Ciprofloxacin	510
Treatment	STARTED	Non-quinolone Antibiotic	519
Treatment	COMPLETED	Ciprofloxacin	487
Treatment	COMPLETED	Non-quinolone Antibiotic	507
Treatment	NOT COMPLETED	Ciprofloxacin	23
Treatment	NOT COMPLETED	Non-quinolone Antibiotic	12
2 or 5 Years Long-term Safety Follow-up	STARTED	Ciprofloxacin	487
2 or 5 Years Long-term Safety Follow-up	STARTED	Non-quinolone Antibiotic	507
2 or 5 Years Long-term Safety Follow-up	4-6 Weeks Post Treatment	Ciprofloxacin	487
2 or 5 Years Long-term Safety Follow-up	4-6 Weeks Post Treatment	Non-quinolone Antibiotic	507

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vomiting	Gastrointestinal disorders	Ciprofloxacin	18	487
other	Vomiting	Gastrointestinal disorders	Non-quinolone Antibiotic	5	507
other	Diarrhoea	Gastrointestinal disorders	Ciprofloxacin	14	487
other	Diarrhoea	Gastrointestinal disorders	Non-quinolone Antibiotic	2	507
other	Abdominal pain upper	Gastrointestinal disorders	Ciprofloxacin	12	487
other	Abdominal pain upper	Gastrointestinal disorders	Non-quinolone Antibiotic	5	507
other	Pyrexia	General disorders	Ciprofloxacin	19	487
other	Pyrexia	General disorders	Non-quinolone Antibiotic	7	507
other	Fatigue	General disorders	Ciprofloxacin	18	487
other	Fatigue	General disorders	Non-quinolone Antibiotic	0	507

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ciprofloxacin
Total, all-cause mortality	Non-quinolone Antibiotic
Total, other adverse events	Ciprofloxacin	206	487
Total, other adverse events	Non-quinolone Antibiotic	76	507
Total, serious adverse events	Ciprofloxacin	25	487
Total, serious adverse events	Non-quinolone Antibiotic	6	507

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ciprofloxacin vs Non-quinolone Antibiotic: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00761462

GET https://conductscience.org/api/trials/v1/NCT00761462/events?page=2

API reference For AI assistants