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Bacterial InfectionsPhase 1NCT01381848

A Study of Doripenem in Infants Less Than 12 Weeks of Age

A Phase 1 study testing Doripenem in people with Bacterial Infections, run by Janssen Research & Development, LLC at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous… Read more about this study

Who is it for?
Ages Up to 12 weeks
Conditions the study is for
Bacterial Infections
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
52 participants
Where
13 sitesin 3 countries
Study dates
Oct 2009to Apr 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 12 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement
  • Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics
  • Patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age
  • 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 as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator
  • Patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure
  • 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 indwelling 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

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

United States7 sites

  • Study site

    Houston, Texas

  • Study site

    Little Rock, Arkansas

  • Study site

    New Brunswick, New Jersey

  • Study site

    Orange, California

  • Study site

    Royal Oak, Michigan

  • Study site

    Salt Lake City, Utah

  • Study site

    Toledo, Ohio

Other trials in United States

United Kingdom5 sites

  • Study site

    Chertsey

  • Study site

    Exeter

  • Study site

    Liverpool

  • Study site

    Manchester

  • Study site

    Norwich

Other trials in United Kingdom

Belgium1 site

  • Study site

    Leuven

Other trials in Belgium

About this study

Official title: An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.

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) pharmacokinetic study (a study to observe how the drug is absorbed and distributed within the body) to measure drug levels of doripenem in hospitalized but medically stable infants (term and preterm), <12 weeks of chronological age (CA) (age since time of birth) who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with intravenous (i.v.) (administered in a vein) antibiotics. Doripenem will be administered alone at any time after the first dose of a nonstudy antibiotic is administered to the patient. Doripenem is not being used in this study to treat infection and it will not replace the patient's prescribed antibiotic(s). The duration of the study will be up to 9 days for each patient. Patients' safety will be monitored throughout the study by a safety committee who will review safety information at least once a month or after every 8 patients are enrolled and dosed. Safety evaluation will include, but will not be limited to, adverse events, clinical laboratory tests, and vital signs. A single dose of study drug (doripenem) will be administered to patients in a hospitalized setting. Patients <8 weeks CA will receive a 5 mg/kg doripenem 1-hour i.v. infusion, and patients >=8 weeks CA will receive an 8 mg/kg doripenem 1-hour infusion. Study drug will be administerd to the patient alone at any time after the first dose of a nonstudy antibiotic is administered to the patient.

Being tested
Doripenem
Keywords
Doripenem, DORIPED1003, Intravenous, Infection, Colonization, Prophylaxis, Pediatric, Antibiotic, Pharmacokinetics
Medical subject headings
Bacterial Infections, Infections

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=5, form=solution for injection, route=intravenous use, once on Day 1 for patients <8 weeks CA.

  • DoripenemDrug

    Type=exact number, unit=mg/kg, number=8, form=solution for injection, route=intravenous use, once on Day 1 for patients >=8 weeks CA.

Study groups in NCT01381848
Study groupRoleWhat they receive
001ExperimentalDoripenem Type=exact number unit=mg/kg number=5 form=solution for injection route=intravenous use once on Day 1 for patients <8 weeks CA.,Doripenem Type=exact number unit=mg/kg number=8 form=solution for injection route=intravenous use once on Day 1 for patients >=8 weeks CA.
Receives: Drug: Doripenem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Doripenem concentrations in blood samples

    Measured: Before and after study drug administration for 1 day

Secondary outcomes (3)

  1. Number of patients with adverse events

    Measured: Up to Day 7

  2. Changes in clinical laboratory test results

    Measured: From Day -2 to Day 1

  3. Changes in vital signs measurements

    Measured: From Day -2 to Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381848
Sponsor's protocol ID
CR016192
Other IDs
DORIPED1003
Status last verified
Jan 2013
First submitted
21 Apr 2011
Last updated
10 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Cirillo I, Vaccaro N, Castaneda-Ruiz B, Redman R, Cossey V, Bradley JS, Allegaert K. Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age. Antimicrob Agents Chemother. 2015 Aug;59(8):4742-9. doi: 10.1128/AAC.00485-15. Epub 2015 May 26.

    PubMed 26014957

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doripenem in people with Bacterial Infections, run by Janssen Research & Development, LLC at 13 sites in 3 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 4 inclusion and 6 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, United Kingdom, 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 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?

Doripenem concentrations in blood samples (time frame: Before and after study drug administration for 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381848, which also lists 1 linked publication.

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 10 Jan 2013.

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