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CompletedNCT00761462Updated Jul 31, 2015Results posted

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

A Phase 3 interventional study of Ciprofloxacin and Non-quinolone antibiotic in Infectious Diseases, sponsored by Bayer. Completed at 67 sites in 2 countries. Open to participants aged 2 Months to 16 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,029
Allocation
Non-randomized
Ages
2 Months to 16 Years
Sex
All
01

Study summary

Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.

Read the detailed description

This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.

02

Conditions studied

  • Infectious Diseases

Keywords

  • Pediatrics
  • Safety
  • Musculoskeletal System
  • Neurologic Manifestations
  • Joint Diseases
  • Joint Deformities, Acquired
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 1,029 is above the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is >/= 2 months of age through 16 years of age
  • A parent/caregiver must sign an informed consent
  • Patient must provide assent, as appropriate based on local institutional review board guidelines

Exclusion criteria

Exclusion Criteria:

  • Patients presenting with the following conditions:

    • exacerbations of cystic fibrosis (CF)
    • meningitis
    • Brain abscess
    • bacterial endocarditis,
    • Bone and joint infections

  • having any of the following conditions but lacking a personal history may be admitted to the trial:

    • Arthritis
    • Juvenile rheumatoid arthritis (JRA)
    • Rheumatoid arthritis (RA)
    • Systemic lupus erythematosis (SLE)
    • History of rheumatic fever
    • Psoriasis
    • Inflammatory bowel disease
    • Osteoarthritis (OA)
  • Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
  • Patients with any pre-treatment baseline musculoskeletal exam abnormalities
  • Known risk of experiencing seizures, a history of any convulsive disorders
  • Requiring any concomitant therapeutic course of systemic antibacterial agent
  • Participation in any industry-sponsored clinical drug development study within one month prior to this study
  • Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin > 3 times upper limit of normal)
  • Known significant renal insufficiency (calculated creatinine clearance of \< 30 ml/min/1.73 m²)
  • Are pregnant or lactating, or are sexually active and using unreliable contraception.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,029 participants (actual)

Study arms

  • Experimental
    Ciprofloxacin

    Subjects receiving Ciprofloxacin (group followed-up for 5 years)

    Drug: Ciprofloxacin

  • Active comparator
    Non-quinolone antibiotic

    Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

    Drug: Non-quinolone antibiotic

Interventions

  • DrugCiprofloxacin

    Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label

  • DrugNon-quinolone antibiotic

    Common used dose and route

06

What researchers measure

Primary outcomes

  1. Incidence of Arthropathy (Cumulative)

    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.

    Time frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

  2. Incidence of Nervous System Events (Cumulative)

    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.

    Time frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

07

Results

Posted Apr 14, 2009
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).

Participant flow

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.

Treatment
Participant flow — Treatment
MilestoneCiprofloxacinNon-quinolone Antibiotic
Started510519
Completed487507
Not completed2312
Withdrew: Subjects never received study medication2312
2 or 5 Years Long-term Safety Follow-up
Participant flow — 2 or 5 Years Long-term Safety Follow-up
MilestoneCiprofloxacinNon-quinolone Antibiotic
Started487507
4-6 weeks post treatment487507
1 year follow-up485507
Completed333456
Not completed15451
Withdrew: Death40
Withdrew: Lost to follow-up7530
Withdrew: Withdrawal by subject7521

Outcome measures

PrimaryIncidence of Arthropathy (Cumulative)

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.

Time frame:
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Reported as:
Number · participants
Incidence of Arthropathy (Cumulative)
participantsCiprofloxacinNon-quinolone Antibiotic
4-6 weeks after treatment399
1 year after treatment6416
2 or 5 years after treatment11220
PrimaryIncidence of Nervous System Events (Cumulative)

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.

Time frame:
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Reported as:
Number · participants
Incidence of Nervous System Events (Cumulative)
participantsCiprofloxacinNon-quinolone Antibiotic
4-6 weeks after treatment3810
1 year after treatment4913
2 or 5 years after treatment5617

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ciprofloxacin—25/487 (5.1%)206/487 (42.3%)
Non-quinolone Antibiotic—6/507 (1.2%)76/507 (15%)
Most frequent serious events
Showing 10 of 39
Most frequent serious events
EventCiprofloxacinNon-quinolone Antibiotic
PyrexiaGeneral disorders4/4870/507
NeutropeniaBlood and lymphatic system disorders3/4870/507
Acute lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/4870/507
Clostridium difficile colitisInfections and infestations2/4870/507
Otitis mediaInfections and infestations2/4870/507
SepsisInfections and infestations2/4870/507
AsthmaRespiratory, thoracic and mediastinal disorders0/4872/507
Haemolytic uraemic syndromeBlood and lymphatic system disorders1/4870/507
Febrile neutropeniaBlood and lymphatic system disorders1/4870/507
Cardiac arrestCardiac disorders1/4870/507
Most frequent other events
Showing 10 of 15
Most frequent other events
EventCiprofloxacinNon-quinolone Antibiotic
ArthropathyMusculoskeletal and connective tissue disorders112/48720/507
ArthralgiaMusculoskeletal and connective tissue disorders84/48713/507
Pain in extremityMusculoskeletal and connective tissue disorders36/4877/507
HeadacheNervous system disorders31/4878/507
Otitis mediaInfections and infestations20/48715/507
PyrexiaGeneral disorders19/4877/507
VomitingGastrointestinal disorders18/4875/507
FatigueGeneral disorders18/4870/507
Upper respiratory tract infectionInfections and infestations17/4878/507
InsomniaPsychiatric disorders17/4874/507

Baseline characteristics

Age, Customized
Age, Customized(participants)CiprofloxacinNon-quinolone AntibioticTotal
>= 2 months through 12 month374885
>=13 months through 23 month4852100
>=2 years through 5 years150165315
>= 6 years through 11 years194223417
>=12 years through 16 years581977
Sex: Female, Male
Sex: Female, Male(Participants)CiprofloxacinNon-quinolone AntibioticTotal
Female269242511
Male218265483
Region of Enrollment
Region of Enrollment(participants)CiprofloxacinNon-quinolone AntibioticTotal
United States476503979
Canada11415
Type of infection, pre-treatment
Type of infection, pre-treatment(participants)CiprofloxacinNon-quinolone AntibioticTotal
Category 1, Otitis Media143207350
Category 2, Pharyngitis / Tonsillitis39148187
Category 3, Urinary Tract10512117
Category 4, Sinusitis394786
Category 5, Pyelonephritis24832
Category 6, Pneumonia121729
Category 7, Bronchitis7714
Category 8, Abscess7613
Category 9, Skin Infection6713
Category 10, External Otitis10111
Category 11, Wound Infection729
Category 12, Other Respiratory Tract Infection268
Category 13, Bacteremia617
Category 14, Shigellosis707
Category 15, Acute Bronchitis257
Category 16, Pseudomonas Infections606
Category 17, Abscess with cellulitis246
Category 18, Mastoiditis505
Category 19, Cystitis505
Category 20, Other532982
08

Study locations

67 sites
  • Mobile, Alabama 36608, United States
  • Fort Smith, Arkansas 72903, United States
  • Corona, California 92879, United States
  • Fountain Valley, California 92708, United States
  • Long Beach, California 90806, United States
  • Orange, California 92868-3974, United States
  • Pico Rivera, California 90660, United States
  • San Bernardino, California 92411, United States
  • San Luis Obispo, California 93405, United States
  • Centennial, Colorado 80112, United States
  • Denver, Colorado 80218, United States
  • Ft. Walton Beach, Florida 32548, United States
  • Gainesville, Florida 32610-0254, United States
  • Hialeah, Florida 33013, United States
  • Jacksonville, Florida 32209, United States
  • Jupiter, Florida 33458, United States
  • Miami, Florida 33155, United States
  • Pensacola, Florida 32504, United States
  • Tampa, Florida 33606, United States
  • Tampa, Florida 33607, United States
  • Snellville, Georgia 30078, United States
  • Honolulu, Hawaii 96813, United States
  • Idaho Falls, Idaho 83404, United States
  • Park Ridge, Illinois 60068-1174, United States
  • Springfield, Illinois 62701, United States
  • Indianapolis, Indiana 46202, United States
  • Overland Park, Kansas 66215, United States
  • Bardstown, Kentucky 40004, United States
  • New Orleans, Louisiana 70118-5799, United States
  • Boston, Massachusetts 02115, United States
  • Red Wing, Minnesota 55066-0095, United States
  • Omaha, Nebraska 68114, United States
  • Omaha, Nebraska 68131, United States
  • Las Vegas, Nevada 89109, United States
  • Hackensack, New Jersey 07601-1991, United States
  • Voorhees, New Jersey 08043, United States
  • Bronx, New York 10461, United States
  • New Hyde Park, New York 11040, United States
  • New York, New York 10021-4885, United States
  • New York, New York 10032, United States
  • Stony Brook, New York 11794-8111, United States
  • Durham, North Carolina 27710, United States
  • Wilmington, North Carolina 28401, United States
  • Akron, Ohio 44308-1062, United States
  • Cleveland, Ohio 44109-1998, United States
  • Dayton, Ohio 45404-1815, United States
  • Youngstown, Ohio 44501-0240, United States
  • Oklahoma City, Oklahoma 73104, United States
  • Oklahoma City, Oklahoma 73120, United States
  • Tulsa, Oklahoma 74135, United States
  • Elverson, Pennsylvania 19520, United States
  • Havertown, Pennsylvania 19083, United States
  • Charleston, South Carolina 29425, United States
  • Memphis, Tennessee 38105-2729, United States
  • Austin, Texas 78756, United States
  • Benbrook, Texas 76126, United States
  • El Paso, Texas 79925, United States
  • Fort Worth, Texas 76104, United States
  • Galveston, Texas 77555-0371, United States
  • Houston, Texas 77024, United States
  • Houston, Texas 77030, United States
  • Temple, Texas 76508, United States
  • Layton, Utah 84041, United States
  • Norfolk, Virginia 23510, United States
  • Richmond, Virginia 23298, United States
  • Morgantown, West Virginia 26506, United States
  • Montreal, Quebec H3H 1P3, Canada
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00761462
Lead sponsor
Bayer
First posted
Sep 29, 2008
Start date
Oct 1999
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Apr 14, 2009
Last update
Jul 31, 2015

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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