Cystitis / Pyelonephritis / Cystic Fibrosis / AnthraxNCT02555059
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
An observational study of Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax, run by Bayer at 1 site in Japan.
Trial summary
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
- What is being tested?
- Cipro (Ciprofloxacin, BAYQ3939)
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 15 Jul 2016to 13 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa, are enrolled after the decision for treatment with Ciproxan injection has been made by the investigator.
Who may be able to join
- Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa.
- Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Ciproxan® Injection in Pediatrics
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
Read the detailed description
This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.
- Being tested
- Cipro (Ciprofloxacin, BAYQ3939)
- Keywords
- Ciprofloxacin, Japan, Post-marketing surveillance
- Medical subject headings
- Cystitis, Pyelonephritis, Cystic Fibrosis, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipro (Ciprofloxacin, BAYQ3939)Drug
Treatment parameters following the physician's decision based on the summary of product characteristics.
| Study group | Role | What they receive |
|---|---|---|
| BAYQ3939 | Pediatrics patients treated with Ciproxan injection in daily clinical practice. Receives: Drug: Cipro (Ciprofloxacin, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of musculoskeletal adverse events.
Measured: Up to 12 months
Secondary outcomes (4)
Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)
Measured: At week 6
Number of participants with adverse events as measure of safety and tolerability
Measured: At week 4
Efficacy
Rated by physician with 3-grade scale
Measured: Up to 2 weeks
Number of participants with adverse events based on abnormal laboratory measurements
Measured: At week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start15 Jul 2016
- Primary completion17 Dec 2018
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis / Pyelonephritis / Cystic Fibrosis / AnthraxStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555059
- Sponsor's protocol ID
- 18235
- Status last verified
- Feb 2020
- First submitted
- 18 Sep 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Ciproxan® Injection in Pediatrics
- ClinicalTrials.gov ID
- NCT02555059
- Acronym / sponsor ID
- 18235
- Keywords
- Ciprofloxacin, Japan, Post-marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
Detailed description
This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAYQ3939 | – | Drug: Cipro (Ciprofloxacin, BAYQ3939)Pediatrics patients treated with Ciproxan injection in daily clinical practice. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa, are enrolled after the decision for treatment with Ciproxan injection has been made by the investigator.
Key inclusion criteria (2 listed)
- Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa.
- Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Cipro (Ciprofloxacin, BAYQ3939)Treatment parameters following the physician's decision based on the summary of product characteristics. | Drug | BAYQ3939 |
Primary outcome
Number of musculoskeletal adverse events.
Time frame: Up to 12 months
4 secondary outcomes
Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)
Time frame: At week 6
Number of participants with adverse events as measure of safety and tolerability
Time frame: At week 4
Efficacy
Time frame: Up to 2 weeks
Number of participants with adverse events based on abnormal laboratory measurements
Time frame: At week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax, run by Bayer at 1 site in Japan.
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 2 inclusion and 1 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of musculoskeletal adverse events. (time frame: Up to 12 months). 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 28 Feb 2020.