PneumoniaPhase 4NCT00986102

PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

A Phase 4 study testing doripenem in people with Pneumonia and Pneumonia, Ventilator-Associated, run by Janssen Research & Development, LLC at 16 sites in 5 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 understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract 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: 216 participants
Where: 16 sitesin 5 countries
Study dates: 17 Jul 2009to 9 Sep 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis

Who cannot join

Pregnant or lactating females
Allergies to Doripenem or its derivatives
Infected by a bacteria that is resistant to Doripenem
Taking probenecid
Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems
Severe kidney disease, in an unstable disease state and assessed as unlikely to survive until the study follow up period
Signs of severe sepsis with treatment failure with other carbapenems, who received other carbapenem within 2 weeks before first dose of study drug, and who has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Trial locations and contacts

16 sites in 5 countries.

Country

City, postcode or hospital

16 sites in 5 countries

Malaysia9 sites

Study site
Ipoh
Study site
Johor Bahru
Study site
Kota Bharu
Study site
Kuala Lumpur
Study site
Kuala Lumpur K Lumpur
Study site
Kuala Selangor
Study site
Pulau Pinang
Study site
Seremban
Study site
Terengganu

Other trials in Malaysia

Indonesia3 sites

Study site
Bandung
Study site
Jakarta
Study site
Surabaya

Other trials in Indonesia

Vietnam2 sites

Study site
Hanoi
Study site
Ho Chi Minh City

Other trials in Vietnam

Hong Kong1 site

Study site
Hong Kong

Other trials in Hong Kong

Singapore1 site

Study site
Singapore

Other trials in Singapore

About this study

Official title: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.

Read the detailed description

This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days

Conditions: Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections
Being tested: doripenem
Keywords: Carbapenem, Doripenem, Doribax, Nosocomial pneumonia, Intra-abdominal infections, Urinary tract infection
Medical subject headings: Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections, Healthcare-Associated Pneumonia, Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

doripenemDrug
500mg vial by injection every 8 hours for 5 to 14 days

Study groups in NCT00986102
Study group	Role	What they receive
001	Other	doripenem 500mg vial by injection every 8 hours for 5 to 14 days Receives: Drug: doripenem

What is being measured

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

Number of Participants With the Usage of Doripenem as Per the Approved Indication
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Measured: 5 to 14 days
Number of Participants With Different Mode of Usage of Doripenem
Measured: 5 to 14 days
Duration of Antibiotic Therapy
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Measured: 5 to 14 days
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.
Measured: Baseline (Day -1)

Secondary outcomes (6)

Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Measured: Day 5 or Day 7 or Day 14
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Measured: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Measured: Day 5 or Day 7 or Day 14
Medical Resource Utilization
Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
Measured: From Baseline (Day -1) upto the duration of hospital stay of a participant
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Measured: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Measured: Within 28 days after EOT (Day 5 or Day 7 or Day 14)

Timeline

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

17 Jul 20099 Sep 2011

First posted29 Sep 2009 (estimated)
Study start17 Jul 2009
Primary completion5 Sep 2011
Study completion9 Sep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986102
Sponsor's protocol ID: CR016321
Other IDs: DORIBAC4007
Status last verified: Oct 2024
First submitted: 25 Sep 2009
Last updated: 19 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No

Publications

Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, Garcia J. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents. 2014 Apr;43(4):353-60. doi: 10.1016/j.ijantimicag.2014.01.017. Epub 2014 Feb 15.
PubMed 24636429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
ClinicalTrials.gov ID: NCT00986102
Acronym / sponsor ID: CR016321
Conditions: Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections
Keywords: Carbapenem, Doripenem, Doribax, Nosocomial pneumonia, Intra-abdominal infections, Urinary tract infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson (Hong Kong) Ltd.
Study start: 17 Jul 2009 (actual)
Primary completion: 5 Sep 2011 (actual)
Study completion: 9 Sep 2011 (actual)
First posted: 29 Sep 2009 (estimated)
Results: Posted 7 Feb 2013

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 understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
001	Other	Drug: doripenemdoripenem 500mg vial by injection every 8 hours for 5 to 14 days

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis

Key exclusion criteria (7 listed)

Pregnant or lactating females
Allergies to Doripenem or its derivatives
Infected by a bacteria that is resistant to Doripenem
Taking probenecid
Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems

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
doripenem500mg vial by injection every 8 hours for 5 to 14 days	Drug	001

Primary outcome

Number of Participants With the Usage of Doripenem as Per the Approved Indication
Time frame: 5 to 14 days
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Number of Participants With Different Mode of Usage of Doripenem
Time frame: 5 to 14 days
Duration of Antibiotic Therapy
Time frame: 5 to 14 days
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Time frame: Baseline (Day -1)
APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.

6 secondary outcomes

Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Time frame: Day 5 or Day 7 or Day 14
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Time frame: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Time frame: Day 5 or Day 7 or Day 14
Medical Resource Utilization
Time frame: From Baseline (Day -1) upto the duration of hospital stay of a participant
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Time frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Time frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)

Results and safety

Results posted to the registry on 7 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nosocomial Pneumonia (NP)	53	52
Ventilator-Associated Pneumonia (VAP)	77	75
Complicated Urinary Tract Infection (cUTI)	19	19
Complicated Intra-abdominal Infection (cIAI)	67	66

Primary outcome: Number of Participants With the Usage of Doripenem as Per the Approved Indication

Time frame: 5 to 14 days. Number. Unit: Participants

Measure	Nosocomial Pneumonia (NP) n = 53	Ventilator-Associated Pneumonia (VAP) n = 77	Complicated Urinary Tract Infection (cUTI) n = 19
Early onset of NP	23	0	0
Late onset of NP	30	0	0
Early onset of VAP	0	32	0
Late onset of VAP	0	45	0
Acute Pyelonephritis	0	0	11
Emphysematous Pyelonephritis	0	0	1
Prostate Infection	0	0	1
Pyelonephritis	0	0	1

Population analysed: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Primary outcome: Number of Participants With Different Mode of Usage of Doripenem

Time frame: 5 to 14 days. Number. Unit: Participants

Measure	Nosocomial Pneumonia (NP) n = 53	Ventilator-Associated Pneumonia (VAP) n = 77	Complicated Urinary Tract Infection (cUTI) n = 19	Complicated Intra-abdominal Infection (cIAI) n = 67
Monotherapy	41	66	18	62
Combination Therapy	12	11	1	5
First Line Therapy	16	33	3	30
Second Line Therapy	37	44	16	37

Population analysed: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Primary outcome: Duration of Antibiotic Therapy

Time frame: 5 to 14 days. Mean (Standard Deviation). Unit: Days

Measure	Nosocomial Pneumonia (NP) n = 53	Ventilator-Associated Pneumonia (VAP) n = 77	Complicated Urinary Tract Infection (cUTI) n = 19	Complicated Intra-abdominal Infection (cIAI) n = 67
Duration of doripenem therapy	7.4 (3.51)	9.2 (4.67)	6.9 (2.46)	6.9 (2.86)
Duration of doripenem plus oral antibiotic therapy	7.5 (3.57)	9.9 (6.07)	9.1 (3.94)	8.3 (4.50)

Population analysed: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Primary outcome: Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score

Time frame: Baseline (Day -1). Number. Unit: Participants

Measure	Nosocomial Pneumonia (NP) n = 53	Ventilator-Associated Pneumonia (VAP) n = 77	Complicated Urinary Tract Infection (cUTI) n = 19	Complicated Intra-abdominal Infection (cIAI) n = 67
APACHE II score: less than or equal to 14	34	50	11	58
APACHE II score: 15 to 19	8	15	3	6
APACHE II score: 20 to 24	4	7	1	2
APACHE II score: 25 to 29	2	4	0	0
APACHE II score: greater than or equal to 30	1	1	0	0
Missing	4	0	4	1

Population analysed: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nosocomial Pneumonia (NP)	22 of 53 (41.5%)	27 of 53 (50.9%)	Not reported
Ventilator-Associated Pneumonia (VAP)	24 of 77 (31.2%)	38 of 77 (49.4%)	Not reported
Complicated Urinary Tract Infection (cUTI)	3 of 19 (15.8%)	11 of 19 (57.9%)	Not reported
Complicated Intra-abdominal Infection (cIAI)	15 of 67 (22.4%)	32 of 67 (47.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24636429Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, Garcia J. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents. 2014 Apr;43(4):353-60. doi: 10.1016/j.ijantimicag.2014.01.017. Epub 2014 Feb 15.

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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 Clinical Trial study director

Janssen Research & Development, LLC

16 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing doripenem in people with Pneumonia and Pneumonia, Ventilator-Associated, run by Janssen Research & Development, LLC at 16 sites in 5 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 1 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: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Malaysia, Indonesia, Vietnam, Hong Kong, Singapore. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With the Usage of Doripenem as Per the Approved Indication (time frame: 5 to 14 days). The study lists 4 primary outcomes in all. 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 NCT00986102, 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 19 Nov 2024.