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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004622-18 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Experimental | Subjects receiving Ciprofloxacin (group followed-up for 5 years) |
|
| Non-quinolone antibiotic | Active Comparator | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin | Subjects receiving Ciprofloxacin (group followed-up for 5 years) |
| FG001 | Non-quinolone Antibiotic | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Non-quinolone antibiotic | Drug | Common used dose and route |
|
| 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 |
| Fort 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 Township | New Jersey | 08043 | 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 |
| The Bronx | New York | 10461 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 2 or 5 Years Long-term Safety Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | Subjects receiving Ciprofloxacin (group followed-up for 5 years) |
| BG001 | Non-quinolone Antibiotic | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Type of infection, pre-treatment | Type of infection, pre-treatment, which qualified patients for long term safety evaluation | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients valid for safety (all patients confirmed to have received at least one dose of study drug) | Posted | Number | participants | 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Patients valid for safety (all patients confirmed to have received at least one dose of study drug). | Posted | Number | participants | 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin | Subjects receiving Ciprofloxacin (group followed-up for 5 years) | 25 | 487 | 206 | 487 | ||
| EG001 | Non-quinolone Antibiotic | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) | 6 | 507 | 76 | 507 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyelonephritits | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Central nervous system leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vesicoureteric reflux | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pelvi- ureteric obstruction | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA11.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA11.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA11.0 | Non-systematic Assessment |
|
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).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D009461 | Neurologic Manifestations |
| D007592 | Joint Diseases |
| D016916 | Joint Deformities, Acquired |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Withdrawal by Subject |
|
|
| >=2 years through 5 years |
|
| >= 6 years through 11 years |
|
| >=12 years through 16 years |
|
| Male |
|
| Canada |
|
| Category 2, Pharyngitis / Tonsillitis |
|
| Category 3, Urinary Tract |
|
| Category 4, Sinusitis |
|
| Category 5, Pyelonephritis |
|
| Category 6, Pneumonia |
|
| Category 7, Bronchitis |
|
| Category 8, Abscess |
|
| Category 9, Skin Infection |
|
| Category 10, External Otitis |
|
| Category 11, Wound Infection |
|
| Category 12, Other Respiratory Tract Infection |
|
| Category 13, Bacteremia |
|
| Category 14, Shigellosis |
|
| Category 15, Acute Bronchitis |
|
| Category 16, Pseudomonas Infections |
|
| Category 17, Abscess with cellulitis |
|
| Category 18, Mastoiditis |
|
| Category 19, Cystitis |
|
| Category 20, Other |
|
| 2 or 5 years after treatment |
|
|