A Phase 2 interventional study of Imipenem/cilastatin and Imipenem/cilastatin in Pneumonia, Ventilator-Associated, Pneumonia, Bacterial and Pneumonia, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.
This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), multicenter study that will evaluate the safety and tolerability of doripenem (an antibiotic used to treat infections) in patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Approximately 250 patients will be assigned in a 3:1 ratio to receive doripenem or imipenem/cilastatin (188 patients randomized to receive doripenem and 62 patients randomized to receive imipenem/cilastatin). Furthermore, patients who receive doripenem or imipenem/cilastatin will be stratified by disease (VAP or cIAI). Therefore, for reporting purposes, there will be 4 groups: Patients with VAP treated with doripenem, patients with VAP treated with imipenem/cilastatin, patients with cIAI treated with doripenem, and patients with cIAI treated with imipenem/cilastatin. Study drug will be administered intravenously (iv) (through a vein) for 7 to 14 days for patients with VAP and for 5 to 14 days for patients with cIAI. The maximum duration of study drug is 14 days. Vancomycin and/or amikacin may be added to the study drug regimen as adjunctive therapy for those patients who meet study specified criteria. The recommended dosage of vancomycin is 1 g every 12 hours administered by iv infusion. The addition of amikacin is at the discretion of the investigator for patients with VAP (not cIAI) and the recommended dosing regimen for amikacin is 15 mg/kg given iv once a day. Alternative amikacin regimens or other aminoglycoside regimens may be permitted. Safety will be assessed during the study by the monitoring of adverse events, evaluation of laboratory test results, and changes in vital signs. The primary endpoint of this study is to assess the overall incidence of treatment-emergent adverse events (TEAEs) from the initiation of the first infusion of study drug and up to 30 days after the completion of study drug therapy. Treatment-emergent adverse events are defined as adverse events that occur or worsen between the initial infusion of study drug up to 30 days after the last dose of study drug. The hypothesis for this study is that doripenem has a similar safety profile to imipenem. Doripenem (1g at 8-hour intervals over a period of 4 hours) or imipenem/cilastatin (1g at 8-hours over a period of 1 hour) will be administered by intravenous (iv) infusion (delivery of drug slowly into the vein over a period of time). Patients diagnosed with ventilator associated pneumonia (VAP) will be treated for 7 to 14 days and patients with complicated intra-abdominal infections (cIAI) will be treated for 5 to 14 days.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's enrollment of 146 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Drug: Doripenem
Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Drug: Imipenem/cilastatin
Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion
Drug: Doripenem
Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion
Drug: Imipenem/cilastatin
Drug pages: Imipenem · Cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Drug pages: Imipenem · Cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
Time frame: from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy
Patients With VAP Who Were Clinically Cured
clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.
Time frame: 7 to 14 days after the end of IV therapy
Patients With cIAI Who Were Clinically Cured
clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.
Time frame: 7 to 14 days after the end of IV therapy
| Milestone | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| Started | 49 | 15 | 62 | 20 |
| Treated | 48 | 15 | 61 | 19 |
| Completed | 41 | 13 | 54 | 15 |
| Not completed | 8 | 2 | 8 | 5 |
| Withdrew: Adverse event | 2 | 0 | 1 | 0 |
| Withdrew: Death | 4 | 2 | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 | 3 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 1 |
| Withdrew: Other | 1 | 0 | 2 | 1 |
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
| participants | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). | 42 | 13 | 37 | 15 |
clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.
| participants | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| Patients With VAP Who Were Clinically Cured | 16 | 7 | — | — |
clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.
| participants | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| Patients With cIAI Who Were Clinically Cured | — | — | 39 | 9 |
Collected over All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VAP Treated With Doripenem | — | 16/48 (33.3%) | 42/48 (87.5%) |
| VAP Treated With Imipenem/Cilastatin | — | 4/15 (26.7%) | 13/15 (86.7%) |
| cIAI Treated With Doripenem | — | 11/61 (18%) | 37/61 (60.7%) |
| cIAI Treated With Imipenem/Cilastatin | — | 7/19 (36.8%) | 15/19 (78.9%) |
| Event | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| pneumoniaInfections and infestations | 1/48 | 2/15 | 0/61 | 0/19 |
| intestinal infarctionGastrointestinal disorders | 0/48 | 1/15 | 0/61 | 0/19 |
| intracranial pressure increasedNervous system disorders | 0/48 | 1/15 | 0/61 | 0/19 |
| abdominal abscessInfections and infestations | 1/48 | 0/15 | 1/61 | 1/19 |
| anaemiaBlood and lymphatic system disorders | 0/48 | 0/15 | 0/61 | 1/19 |
| cardiac failure congestiveCardiac disorders | 0/48 | 0/15 | 0/61 | 1/19 |
| gasrointestinal haemorrhageGastrointestinal disorders | 0/48 | 0/15 | 0/61 | 1/19 |
| gastritisGastrointestinal disorders | 0/48 | 0/15 | 0/61 | 1/19 |
| myocardial infarctionCardiac disorders | 0/48 | 0/15 | 1/61 | 1/19 |
| pelvic abscessInfections and infestations | 0/48 | 0/15 | 0/61 | 1/19 |
| Event | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
|---|---|---|---|---|
| constipationGastrointestinal disorders | 3/48 | 3/15 | 1/61 | 2/19 |
| urinary tract infectionInfections and infestations | 5/48 | 3/15 | 0/61 | 1/19 |
| AnaemiaBlood and lymphatic system disorders | 9/48 | 1/15 | 1/61 | 1/19 |
| hypokalaemiaMetabolism and nutrition disorders | 4/48 | 1/15 | 4/61 | 3/19 |
| pneumoniaInfections and infestations | 3/48 | 2/15 | 0/61 | 3/19 |
| pyrexiaGeneral disorders | 5/48 | 2/15 | 5/61 | 3/19 |
| diarrhoeaGastrointestinal disorders | 6/48 | 2/15 | 3/61 | 1/19 |
| bronchospasmRespiratory, thoracic and mediastinal disorders | 6/48 | 0/15 | 0/61 | 0/19 |
| decubitus ulcerSkin and subcutaneous tissue disorders | 6/48 | 0/15 | 0/61 | 0/19 |
| hypertensionVascular disorders | 2/48 | 1/15 | 7/61 | 2/19 |
| Age, Customized(participants) | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | Total |
|---|---|---|---|---|---|
| <65 years | 35 | 11 | 48 | 16 | 110 |
| >=65 years | 14 | 4 | 14 | 4 | 36 |
| Sex: Female, Male(Participants) | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | Total |
|---|---|---|---|---|---|
| Female | 12 | 6 | 25 | 5 | 48 |
| Male | 37 | 9 | 37 | 15 | 98 |
| Region of Enrollment(participants) | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | Total |
|---|---|---|---|---|---|
| North America | 14 | 3 | 24 | 7 | 48 |
| Europe | 19 | 7 | 15 | 4 | 45 |
| South America | 16 | 5 | 23 | 9 | 53 |
No study locations are listed for this record.
The record gives a start of Oct 2007, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2010, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Doripenem
Pneumonia, Ventilator-Associated →
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. →