MeningitisPhase 1NCT01366651
A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age
A Phase 1 study testing Doripenem in people with Meningitis, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Meningitis
- What is being tested?
- Doripenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 1
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is expected to require hospitalization for the entire open-label phase of the study.
- Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
- Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.
- Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.
Who cannot join
- Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
- Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.
- Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before screening.
- History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
- Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
- Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.
- Patients concomitantly treated with probenecid or valproic acid (VPA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological Age
The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.
Read the detailed description
This is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) study to characterize the penetration of doripenem in the cerebral spinal fluid (CSF) in pediatric patients <1 year of age who are hospitalized but medically stable, and who have a documented or suspected infection and are planning to, or undergoing treatment with antibiotics administered intravenously (in a vein, abbreviated as "IV"). Doripenem will not replace the patients' prescribed antibiotic(s). The study includes 3 phases: a pretreatment phase consisting of an up to 24-hour screening period; a 2-day open-label treatment period when doripenem will be administered, and CSF and blood samples will be collected, and a follow-up visit approximately 1 week after administration of the last dose of doripenem. The total duration of the study is approximately 10 days. During the study, patients <12 weeks of age will receive a 10 mg/kg doripenem 1-hour IV infusion via a central or peripheral venous line (a catheter inserted in a large vein) every 8 hours; patients 12 weeks to <1 year of age will receive a 30 mg/kg doripenem 1-hour IV infusion every 8 hours. A total of 5 doses of doripenem will be administered over a 2-day period while the patient is in the hospital.
- Conditions
- Meningitis
- Being tested
- Doripenem
- Keywords
- Doripenem, DORIPED1002, Intravenous, Pediatric, Antibiotic, Meningitis
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoripenemDrug
Type=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age.
DoripenemDrug
Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Doripenem | Experimental | Doripenem Type=exact number unit=mg/kg number=10 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials.,Doripenem Type=exact number unit=mg/kg number=30 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age. Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials. Receives: Drug: Doripenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doripenem concentrations in CSF and plasma
Measured: For up to 2 days
Secondary outcomes (7)
Number of patients with adverse events
Measured: Up to Day 9
Changes in clinical laboratory test results
Measured: From Day -1 to Day 9
Changes in physical examination results reported as adverse events
Measured: From Day -1 to Day 9
Changes in vital signs measurements
Measured: From Day -1 to Day 9
Changes in concomitant therapy
Measured: From Day -1 to Day 9
The number of patients with changes from baseline in clinical laboratory test results
Measured: From Day -1 to Day 9
The number of patients who receive concomitant therapy
Measured: From Day -1 to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: Trial terminated early per business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Development, L.L.C., Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366651
- Sponsor's protocol ID
- CR016189
- Other IDs
- DORIPED1002, 2011-001114-33
- Status last verified
- Dec 2013
- First submitted
- 14 Apr 2011
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological Age
- ClinicalTrials.gov ID
- NCT01366651
- Acronym / sponsor ID
- CR016189
- Conditions
- Meningitis
- Keywords
- Doripenem, DORIPED1002, Intravenous, Pediatric, Antibiotic, Meningitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated early per business decision.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jun 2011 (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 purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.
Detailed description
This is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) study to characterize the penetration of doripenem in the cerebral spinal fluid (CSF) in pediatric patients <1 year of age who are hospitalized but medically stable, and who have a documented or suspected infection and are planning to, or undergoing treatment with antibiotics administered intravenously (in a vein, abbreviated as "IV"). Doripenem will not replace the patients' prescribed antibiotic(s). The study includes 3 phases: a pretreatment phase consisting of an up to 24-hour screening period; a 2-day open-label treatment period when doripenem will be administered, and CSF and blood samples will be collected, and a follow-up visit approximately 1 week after administration of the last dose of doripenem. The total duration of the study is approximately 10 days. During the study, patients <12 weeks of age will receive a 10 mg/kg doripenem 1-hour IV infusion via a central or peripheral venous line (a catheter inserted in a large vein) every 8 hours; patients 12 weeks to <1 year of age will receive a 30 mg/kg doripenem 1-hour IV infusion every 8 hours. A total of 5 doses of doripenem will be administered over a 2-day period while the patient is in the hospital.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doripenem | Experimental | Drug: DoripenemDoripenem Type=exact number unit=mg/kg number=10 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials.,Doripenem Type=exact number unit=mg/kg number=30 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age. Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient is expected to require hospitalization for the entire open-label phase of the study.
- Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
- Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.
- Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.
Key exclusion criteria (7 listed)
- Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
- Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.
- Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before screening.
- History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
- Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
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 |
|---|---|---|
| DoripenemType=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age. | Drug | Doripenem |
| DoripenemType=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age. | Drug | Doripenem |
Primary outcome
Doripenem concentrations in CSF and plasma
Time frame: For up to 2 days
7 secondary outcomes
Number of patients with adverse events
Time frame: Up to Day 9
Changes in clinical laboratory test results
Time frame: From Day -1 to Day 9
Changes in physical examination results reported as adverse events
Time frame: From Day -1 to Day 9
Changes in vital signs measurements
Time frame: From Day -1 to Day 9
Changes in concomitant therapy
Time frame: From Day -1 to Day 9
The number of patients with changes from baseline in clinical laboratory test results
Time frame: From Day -1 to Day 9
The number of patients who receive concomitant therapy
Time frame: From Day -1 to Day 9
Results and safety
The study was stopped early (reason given: Trial terminated early per business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological AgeLink provided by the sponsor.
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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.
Janssen Research & Development, LLC Development, L.L.C., Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doripenem in people with Meningitis, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Dec 2013. 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 Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial terminated early per business decision.). Results are not available in the source record.
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?
Doripenem concentrations in CSF and plasma (time frame: For up to 2 days). 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 6 Dec 2013.