Hospital-Acquired PneumoniaPhase 2NCT00543608
Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia
A Phase 2 study testing iclaprim and vancomycin in people with Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia, run by Arpida AG.
Trial summary
The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia
- What is being tested?
- iclaprim and vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to May 2009
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:
- hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or
- ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or
- health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:
- hospitalization for at least two days within 90 days of the current infection,
- residence in a nursing home or long-term care facility,
- recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection
Who cannot join
- Acute Physiology and Chronic Health Enquiry (APACHE) II score < 8 or ≥ 25.
- Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.
- Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.
About this study
Official title: Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed to be Due to Gram-Positive Pathogens
The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
- Conditions
- Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia
- Being tested
- iclaprim, vancomycin
- Keywords
- pneumonia, nosocomial pneumonia
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iclaprimDrug
vancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose 1 iclaprim Receives: Drug: iclaprim |
| 2 | Experimental | Dose 2 iclaprim Receives: Drug: iclaprim |
| 3 | Active comparator | vancomycin Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
Measured: at test of cure (TOC) visit
Efficacy: Iclaprim clinical cure rates
Measured: at TOC and end of therapy (EOT)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2009 (estimated)
- Study completionMay 2009 (estimated)
Why it stopped: Trial terminated due to financial resource limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-Acquired PneumoniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arpida AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Willms, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543608
- Sponsor's protocol ID
- ICLA-20-PNE1
- Status last verified
- Feb 2009
- First submitted
- 11 Oct 2007
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed to be Due to Gram-Positive Pathogens
- ClinicalTrials.gov ID
- NCT00543608
- Acronym / sponsor ID
- ICLA-20-PNE1
- Conditions
- Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia
- Keywords
- pneumonia, nosocomial pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated due to financial resource limitations
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Arpida AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 15 Oct 2007 (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 compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: iclaprimDose 1 iclaprim |
| 2 | Experimental | Drug: iclaprimDose 2 iclaprim |
| 3 | Active comparator | Drug: vancomycinvancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:
Key exclusion criteria (3 listed)
- Acute Physiology and Chronic Health Enquiry (APACHE) II score < 8 or ≥ 25.
- Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.
- Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.
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 |
|---|---|---|
| iclaprim | Drug | 1, 2 |
| vancomycin | Drug | 3 |
Primary outcome
Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
Time frame: at test of cure (TOC) visit
Efficacy: Iclaprim clinical cure rates
Time frame: at TOC and end of therapy (EOT)
Safety
Results and safety
The study was stopped early (reason given: Trial terminated due to financial resource limitations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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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.
David Willms, MD principal investigator
Sharp HealthCare
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iclaprim and vancomycin in people with Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia, run by Arpida AG.
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 7 inclusion and 3 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 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 due to financial resource limitations). 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?
Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin (time frame: at test of cure (TOC) visit). The study lists 3 primary outcomes in all. 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 13 Feb 2009.