Infectious DiseasesPhase 3NCT00761462
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
A Phase 3 study testing Ciprofloxacin and Non-quinolone antibiotic in people with Infectious Diseases, run by Bayer at 67 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Ciprofloxacin and Non-quinolone antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 67 sitesin 2 countries
- Study dates
- Oct 1999to Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients presenting with the following conditions:
- exacerbations of cystic fibrosis (CF)
- meningitis
- Brain abscess
- bacterial endocarditis,
- Bone and joint infections
Show all 23Show fewer
- 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.
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States66 sites
Study site
Akron, Ohio, 44308-1062
Study site
Austin, Texas, 78756
Study site
Bardstown, Kentucky, 40004
Study site
Benbrook, Texas, 76126
Study site
Boston, Massachusetts, 02115
Study site
Centennial, Colorado, 80112
Study site
Charleston, South Carolina, 29425
Study site
Cleveland, Ohio, 44109-1998
Study site
Corona, California, 92879
Study site
Dayton, Ohio, 45404-1815
Study site
Denver, Colorado, 80218
Study site
Durham, North Carolina, 27710
Study site
El Paso, Texas, 79925
Study site
Elverson, Pennsylvania, 19520
Study site
Fort Smith, Arkansas, 72903
Study site
Fort Walton Beach, Florida, 32548
Study site
Fort Worth, Texas, 76104
Study site
Fountain Valley, California, 92708
Study site
Gainesville, Florida, 32610-0254
Study site
Galveston, Texas, 77555-0371
Study site
Hackensack, New Jersey, 07601-1991
Study site
Havertown, Pennsylvania, 19083
Study site
Hialeah, Florida, 33013
Study site
Honolulu, Hawaii, 96813
Study site
Houston, Texas, 77024
Study site
Houston, Texas, 77030
Study site
Idaho Falls, Idaho, 83404
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32209
Study site
Jupiter, Florida, 33458
Study site
Las Vegas, Nevada, 89109
Study site
Layton, Utah, 84041
Study site
Long Beach, California, 90806
Study site
Memphis, Tennessee, 38105-2729
Study site
Miami, Florida, 33155
Study site
Mobile, Alabama, 36608
Study site
Morgantown, West Virginia, 26506
Study site
New Hyde Park, New York, 11040
Study site
New Orleans, Louisiana, 70118-5799
Study site
New York, New York, 10021-4885
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23510
Study site
Oklahoma City, Oklahoma, 73104
Study site
Oklahoma City, Oklahoma, 73120
Study site
Omaha, Nebraska, 68114
Study site
Omaha, Nebraska, 68131
Study site
Orange, California, 92868-3974
Study site
Overland Park, Kansas, 66215
Study site
Park Ridge, Illinois, 60068-1174
Study site
Pensacola, Florida, 32504
Study site
Pico Rivera, California, 90660
Study site
Red Wing, Minnesota, 55066-0095
Study site
Richmond, Virginia, 23298
Study site
San Bernardino, California, 92411
Study site
San Luis Obispo, California, 93405
Study site
Snellville, Georgia, 30078
Study site
Springfield, Illinois, 62701
Study site
Stony Brook, New York, 11794-8111
Study site
Tampa, Florida, 33606
Study site
Tampa, Florida, 33607
Study site
Temple, Texas, 76508
Study site
The Bronx, New York, 10461
Study site
Tulsa, Oklahoma, 74135
Study site
Voorhees Township, New Jersey, 08043
Study site
Wilmington, North Carolina, 28401
Study site
Youngstown, Ohio, 44501-0240
About this study
Official title: A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses
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.
- Conditions
- Infectious Diseases
- Being tested
- Ciprofloxacin, Non-quinolone antibiotic
- Keywords
- Pediatrics, Safety, Musculoskeletal System, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired
- Medical subject headings
- Communicable Diseases, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Non-quinolone antibioticDrug
Common used dose and route
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Experimental | Subjects receiving Ciprofloxacin (group followed-up for 5 years) Receives: Drug: Ciprofloxacin |
| Non-quinolone antibiotic | Active comparator | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) Receives: Drug: Non-quinolone antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
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.
Measured: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 1999
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761462
- Sponsor's protocol ID
- 100201
- Other IDs
- 2014-004622-18, 2014
- Status last verified
- Jul 2015
- First submitted
- 26 Sep 2008
- Last updated
- 31 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses
- ClinicalTrials.gov ID
- NCT00761462
- Acronym / sponsor ID
- 100201
- Conditions
- Infectious Diseases
- Keywords
- Pediatrics, Safety, Musculoskeletal System, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 14 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Experimental | Drug: CiprofloxacinSubjects receiving Ciprofloxacin (group followed-up for 5 years) |
| Non-quinolone antibiotic | Active comparator | Drug: Non-quinolone antibioticSubjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- Patients presenting with the following conditions:
- having any of the following conditions but lacking a personal history may be admitted to the trial:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinEither as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label | Drug | Ciprofloxacin |
| Non-quinolone antibioticCommon used dose and route | Drug | Non-quinolone antibiotic |
Primary outcome
Incidence of Arthropathy (Cumulative)
Time frame: 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.
Incidence of Nervous System Events (Cumulative)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Infectious Diseases
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
67 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin and Non-quinolone antibiotic in people with Infectious Diseases, run by Bayer at 67 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Arthropathy (Cumulative) (time frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.