BAY 0 9867 Cipro Pediatric Use Study (QUIP)

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00761462

First received: September 26, 2008

Last updated: June 4, 2012

Last verified: June 2012

History of Changes

Results First Received: December 19, 2008

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Infectious Diseases
Interventions:	Drug: Ciprofloxacin Drug: Non-quinolone antibiotic

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Observational study in which patients were recruited between 1999 and 2002, and followed up for 5 years (ciprofloxacin patients) or 2 years (non-ciprofloxacin patients), monitoring the occurrence of musculoskeletal and central nervous system events.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The decision to treat with ciprofloxacin or a non-quinolone antibiotic was made prior to a patient's enrollment in the study and was based on the particular infection, type of patient, medical history, and the clinical evaluation by the prescribing physician. The study was not randomized.

Reporting Groups

	Description
Ciprofloxacin	Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Non-quinolone Antibiotic	Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Participant Flow for 2 periods

Period 1: Treatment

	Ciprofloxacin	Non-quinolone Antibiotic
STARTED	510 ^[1]	519 ^[1]
COMPLETED	487 ^[2]	507 ^[2]
NOT COMPLETED	23	12
Subjects never received study medication	23	12

[1]	Patients enrolled in study group
[2]	Patients with confirmed intake of study drug

Period 2: 2 or 5 Years Long-term Safety Follow-up

	Ciprofloxacin	Non-quinolone Antibiotic
STARTED	487 ^[1]	507 ^[1]
4-6 Weeks Post Treatment	487	507
1 Year Follow-up	485	507
COMPLETED	333 ^[2]	456 ^[3]
NOT COMPLETED	154	51
Death	4	0
Lost to Follow-up	75	30
Withdrawal by Subject	75	21

[1]	Patients with confirmed intake of study drug entering long-term safety evaluation
[2]	Patients under safety evaluation at end of 5 year safety Follow-up.
[3]	Patients under safety evaluation at end of 2 year safety Follow-up.

Baseline Characteristics

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Reporting Groups

	Description
Ciprofloxacin	Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Non-quinolone Antibiotic	Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Total	Total of all reporting groups

Baseline Measures

	Ciprofloxacin	Non-quinolone Antibiotic	Total
Number of Participants [units: participants]	487	507	994
Age, Customized [units: participants]
>= 2 months through 12 month	37	48	85
>=13 months through 23 month	48	52	100
>=2 years through 5 years	150	165	315
>= 6 years through 11 years	194	223	417
>=12 years through 16 years	58	19	77
Gender [units: participants]
Female	269	242	511
Male	218	265	483
Region of Enrollment [units: participants]
United States	476	503	979
Canada	11	4	15
Type of infection, pre-treatment ^[1] [units: participants]
Category 1, Otitis Media	143	207	350
Category 2, Pharyngitis / Tonsillitis	39	148	187
Category 3, Urinary Tract	105	12	117
Category 4, Sinusitis	39	47	86
Category 5, Pyelonephritis	24	8	32
Category 6, Pneumonia	12	17	29
Category 7, Bronchitis	7	7	14
Category 8, Abscess	7	6	13
Category 9, Skin Infection	6	7	13
Category 10, External Otitis	10	1	11
Category 11, Wound Infection	7	2	9
Category 12, Other Respiratory Tract Infection	2	6	8
Category 13, Bacteremia	6	1	7
Category 14, Shigellosis	7	0	7
Category 15, Acute Bronchitis	2	5	7
Category 16, Pseudomonas Infections	6	0	6
Category 17, Abscess with cellulitis	2	4	6
Category 18, Mastoiditis	5	0	5
Category 19, Cystitis	5	0	5
Category 20, Other	53	29	82

[1]	Type of infection, pre-treatment, which qualified patients for long term safety evaluation

Outcome Measures

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1. Primary:

Incidence of Arthropathy (Cumulative) [ Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment ]

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2. Primary:

Incidence of Nervous System Events (Cumulative) [ Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
Ciprofloxacin	Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Non-quinolone Antibiotic	Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Other Adverse Events

	Ciprofloxacin	Non-quinolone Antibiotic
Total, other (not including serious) adverse events
# participants affected / at risk	206/487	76/507
Gastrointestinal disorders
Vomiting ^{* 1}
# participants affected / at risk	18/487 (3.70%)	5/507 (0.99%)
Diarrhoea ^{* 1}
# participants affected / at risk	14/487 (2.87%)	2/507 (0.39%)
Abdominal pain upper ^{* 1}
# participants affected / at risk	12/487 (2.46%)	5/507 (0.99%)
General disorders
Pyrexia ^{* 2}
# participants affected / at risk	19/487 (3.90%)	7/507 (1.38%)
Fatigue ^{* 2}
# participants affected / at risk	18/487 (3.70%)	0/507 (0.00%)
Infections and infestations
Otitis media ^{* 2}
# participants affected / at risk	20/487 (4.11%)	15/507 (2.96%)
Upper respiratory tract infection ^{* 2}
# participants affected / at risk	17/487 (3.49%)	8/507 (1.58%)
Injury, poisoning and procedural complications
Joint sprain ^{* 2}
# participants affected / at risk	13/487 (2.67%)	5/507 (0.99%)
Contusion ^{* 2}
# participants affected / at risk	11/487 (2.26%)	8/507 (1.58%)
Musculoskeletal and connective tissue disorders
Arthropathy ^{* 2}
# participants affected / at risk	112/487 (23.00%)	20/507 (3.94%)
Arthralgia ^{* 2}
# participants affected / at risk	84/487 (17.25%)	13/507 (2.56%)
Pain in extremity ^{* 2}
# participants affected / at risk	36/487 (7.39%)	7/507 (1.38%)
Nervous system disorders
Headache ^{* 2}
# participants affected / at risk	31/487 (6.37%)	8/507 (1.58%)
Psychiatric disorders
Insomnia ^{* 2}
# participants affected / at risk	17/487 (3.49%)	4/507 (0.79%)
Respiratory, thoracic and mediastinal disorders
Cough ^{* 2}
# participants affected / at risk	16/487 (3.29%)	3/507 (0.59%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 11.0
2	Term from vocabulary, MedDRA11.0

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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).

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00761462 History of Changes
Other Study ID Numbers:	100201
Study First Received:	September 26, 2008
Results First Received:	December 19, 2008
Last Updated:	June 4, 2012
Health Authority:	United States: Food and Drug Administration

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