Trial Outcomes & Findings for BAY 0 9867 Cipro Pediatric Use Study (QUIP) (NCT NCT00761462)
NCT ID: NCT00761462
Last Updated: 2015-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1029 participants
Primary outcome timeframe
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Results posted on
2015-07-31
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.
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.
Participant milestones
| Measure |
Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Treatment
STARTED
|
510
|
519
|
|
Treatment
COMPLETED
|
487
|
507
|
|
Treatment
NOT COMPLETED
|
23
|
12
|
|
2 or 5 Years Long-term Safety Follow-up
STARTED
|
487
|
507
|
|
2 or 5 Years Long-term Safety Follow-up
4-6 Weeks Post Treatment
|
487
|
507
|
|
2 or 5 Years Long-term Safety Follow-up
1 Year Follow-up
|
485
|
507
|
|
2 or 5 Years Long-term Safety Follow-up
COMPLETED
|
333
|
456
|
|
2 or 5 Years Long-term Safety Follow-up
NOT COMPLETED
|
154
|
51
|
Reasons for withdrawal
| Measure |
Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Treatment
Subjects never received study medication
|
23
|
12
|
|
2 or 5 Years Long-term Safety Follow-up
Death
|
4
|
0
|
|
2 or 5 Years Long-term Safety Follow-up
Lost to Follow-up
|
75
|
30
|
|
2 or 5 Years Long-term Safety Follow-up
Withdrawal by Subject
|
75
|
21
|
Baseline Characteristics
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Baseline characteristics by cohort
| Measure |
Ciprofloxacin
n=487 Participants
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
n=507 Participants
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
Total
n=994 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= 2 months through 12 month
|
37 participants
n=39 Participants
|
48 participants
n=41 Participants
|
85 participants
n=35 Participants
|
|
Age, Customized
>=13 months through 23 month
|
48 participants
n=39 Participants
|
52 participants
n=41 Participants
|
100 participants
n=35 Participants
|
|
Age, Customized
>=2 years through 5 years
|
150 participants
n=39 Participants
|
165 participants
n=41 Participants
|
315 participants
n=35 Participants
|
|
Age, Customized
>= 6 years through 11 years
|
194 participants
n=39 Participants
|
223 participants
n=41 Participants
|
417 participants
n=35 Participants
|
|
Age, Customized
>=12 years through 16 years
|
58 participants
n=39 Participants
|
19 participants
n=41 Participants
|
77 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=39 Participants
|
242 Participants
n=41 Participants
|
511 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
218 Participants
n=39 Participants
|
265 Participants
n=41 Participants
|
483 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
476 participants
n=39 Participants
|
503 participants
n=41 Participants
|
979 participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=39 Participants
|
4 participants
n=41 Participants
|
15 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 1, Otitis Media
|
143 participants
n=39 Participants
|
207 participants
n=41 Participants
|
350 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 2, Pharyngitis / Tonsillitis
|
39 participants
n=39 Participants
|
148 participants
n=41 Participants
|
187 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 3, Urinary Tract
|
105 participants
n=39 Participants
|
12 participants
n=41 Participants
|
117 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 4, Sinusitis
|
39 participants
n=39 Participants
|
47 participants
n=41 Participants
|
86 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 5, Pyelonephritis
|
24 participants
n=39 Participants
|
8 participants
n=41 Participants
|
32 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 6, Pneumonia
|
12 participants
n=39 Participants
|
17 participants
n=41 Participants
|
29 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 7, Bronchitis
|
7 participants
n=39 Participants
|
7 participants
n=41 Participants
|
14 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 8, Abscess
|
7 participants
n=39 Participants
|
6 participants
n=41 Participants
|
13 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 9, Skin Infection
|
6 participants
n=39 Participants
|
7 participants
n=41 Participants
|
13 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 10, External Otitis
|
10 participants
n=39 Participants
|
1 participants
n=41 Participants
|
11 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 11, Wound Infection
|
7 participants
n=39 Participants
|
2 participants
n=41 Participants
|
9 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 12, Other Respiratory Tract Infection
|
2 participants
n=39 Participants
|
6 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 13, Bacteremia
|
6 participants
n=39 Participants
|
1 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 14, Shigellosis
|
7 participants
n=39 Participants
|
0 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 15, Acute Bronchitis
|
2 participants
n=39 Participants
|
5 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 16, Pseudomonas Infections
|
6 participants
n=39 Participants
|
0 participants
n=41 Participants
|
6 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 17, Abscess with cellulitis
|
2 participants
n=39 Participants
|
4 participants
n=41 Participants
|
6 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 18, Mastoiditis
|
5 participants
n=39 Participants
|
0 participants
n=41 Participants
|
5 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 19, Cystitis
|
5 participants
n=39 Participants
|
0 participants
n=41 Participants
|
5 participants
n=35 Participants
|
|
Type of infection, pre-treatment
Category 20, Other
|
53 participants
n=39 Participants
|
29 participants
n=41 Participants
|
82 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatmentPopulation: Patients valid for safety (all patients confirmed to have received at least one dose of study drug)
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.
Outcome measures
| Measure |
Ciprofloxacin
n=487 Participants
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
n=507 Participants
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Incidence of Arthropathy (Cumulative)
4-6 weeks after treatment
|
39 participants
|
9 participants
|
|
Incidence of Arthropathy (Cumulative)
1 year after treatment
|
64 participants
|
16 participants
|
|
Incidence of Arthropathy (Cumulative)
2 or 5 years after treatment
|
112 participants
|
20 participants
|
PRIMARY outcome
Timeframe: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatmentPopulation: Patients valid for safety (all patients confirmed to have received at least one dose of study drug).
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.
Outcome measures
| Measure |
Ciprofloxacin
n=487 Participants
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
n=507 Participants
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Incidence of Nervous System Events (Cumulative)
4-6 weeks after treatment
|
38 participants
|
10 participants
|
|
Incidence of Nervous System Events (Cumulative)
1 year after treatment
|
49 participants
|
13 participants
|
|
Incidence of Nervous System Events (Cumulative)
2 or 5 years after treatment
|
56 participants
|
17 participants
|
Adverse Events
Ciprofloxacin
Serious events: 25 serious events
Other events: 206 other events
Deaths: 0 deaths
Non-quinolone Antibiotic
Serious events: 6 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciprofloxacin
n=487 participants at risk
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
n=507 participants at risk
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
3/487
|
0.00%
0/507
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.21%
1/487
|
0.00%
0/507
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.21%
1/487
|
0.00%
0/507
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
1/487
|
0.00%
0/507
|
|
Cardiac disorders
Cardiac disorder
|
0.21%
1/487
|
0.00%
0/507
|
|
Cardiac disorders
Atrial thrombosis
|
0.21%
1/487
|
0.00%
0/507
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/487
|
0.00%
0/507
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/487
|
0.00%
0/507
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/487
|
0.00%
0/507
|
|
General disorders
Pyrexia
|
0.82%
4/487
|
0.00%
0/507
|
|
Infections and infestations
Clostridium difficile colitis
|
0.41%
2/487
|
0.00%
0/507
|
|
Infections and infestations
Otitis media
|
0.41%
2/487
|
0.00%
0/507
|
|
Infections and infestations
Sepsis
|
0.41%
2/487
|
0.00%
0/507
|
|
Infections and infestations
Bacteraemia
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Osteomyelitis
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Perianal abscess
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Pyelonephritits
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Urinary tract infection
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Wound infection
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Bronchitis bacterial
|
0.21%
1/487
|
0.00%
0/507
|
|
Infections and infestations
Wound abscess
|
0.21%
1/487
|
0.00%
0/507
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/487
|
0.00%
0/507
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/487
|
0.00%
0/507
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
1/487
|
0.00%
0/507
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.21%
1/487
|
0.00%
0/507
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.62%
3/487
|
0.00%
0/507
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.21%
1/487
|
0.00%
0/507
|
|
Renal and urinary disorders
Nephropathy
|
0.21%
1/487
|
0.00%
0/507
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.21%
1/487
|
0.00%
0/507
|
|
Renal and urinary disorders
Renal failure acute
|
0.21%
1/487
|
0.00%
0/507
|
|
Reproductive system and breast disorders
Vesicoureteric reflux
|
0.21%
1/487
|
0.00%
0/507
|
|
Renal and urinary disorders
Pelvi- ureteric obstruction
|
0.21%
1/487
|
0.00%
0/507
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.21%
1/487
|
0.00%
0/507
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/487
|
0.20%
1/507
|
|
Infections and infestations
Empyema
|
0.00%
0/487
|
0.20%
1/507
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/487
|
0.20%
1/507
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/487
|
0.20%
1/507
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/487
|
0.39%
2/507
|
Other adverse events
| Measure |
Ciprofloxacin
n=487 participants at risk
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
|
Non-quinolone Antibiotic
n=507 participants at risk
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.7%
18/487
|
0.99%
5/507
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
14/487
|
0.39%
2/507
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
12/487
|
0.99%
5/507
|
|
General disorders
Pyrexia
|
3.9%
19/487
|
1.4%
7/507
|
|
General disorders
Fatigue
|
3.7%
18/487
|
0.00%
0/507
|
|
Infections and infestations
Otitis media
|
4.1%
20/487
|
3.0%
15/507
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
17/487
|
1.6%
8/507
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.7%
13/487
|
0.99%
5/507
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
11/487
|
1.6%
8/507
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
23.0%
112/487
|
3.9%
20/507
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
84/487
|
2.6%
13/507
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
36/487
|
1.4%
7/507
|
|
Nervous system disorders
Headache
|
6.4%
31/487
|
1.6%
8/507
|
|
Psychiatric disorders
Insomnia
|
3.5%
17/487
|
0.79%
4/507
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
16/487
|
0.59%
3/507
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60