Pneumonia Ventilator AssociatedPhase 4NCT01559753
Early-onset Ventilator-associated Pneumonia in Adults: Comparison of 8 Versus 15 Days of Antibiotic Treatment
A Phase 4 study testing Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin and compare 8 to15 days of antibiotic treatment in people with Pneumonia Ventilator Associated, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The duration of treatment of community acquired pulmonary infection varies between 5 and 14 days according to the authors (22), or even 3 days with new drugs having long half-life (2). For nosocomial pulmonary infection, treatment durations are not standardized (5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia Ventilator Associated
- What is being tested?
- Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin and compare 8 to15 days of antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Nov 2002
- Phase
- Phase 4
- 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
- Early onset nosocomial pneumonia in patients under mechanical ventilation since at least 24 h Patients aged 18 years or more The patient must be able to receive either one of the two arms of treatment defined for the study Information on the patient and his family informed consent obtained during the first three days Bacteria sensitive to the specified antibiotic regimen
Who cannot join
- Patients do not match the criteria for inclusion
- 18 years of age, pregnant Patients
- Another infectious outbreak documented the day of the BAL.
- Patients with acquired immunosuppression (blood diseases, HIV,...), induced (immunosuppressive drugs, cancer, radiation therapy) or congenital.
- Steroids for a period exceeding 15 days.
- Leukopenia (1000 GB/mm (or neutropenia (500 PN/mm)
Show all 16Show fewer
- Purulent pleural effusion, pulmonary abscess
- Cystic fibrosis
- Antibiotic treatment according to the following terms:
- Ongoing curative antibiotic therapy
- Antibiotics within 3 days before the diagnosis of VAP, except surgical antibiotic prophylaxis (defined according to the consensus conference "antibiotic prophylaxis in the surgical environment in adult" December 11, 1992) (27)
- Use of antibiotics not authorized in the study (see list)
- Allergy to antibiotics used in the study
- Inclusion in another study assessing antibiotic treatment, either the treatment or prevention of nosocomial pulmonary disease
- Refusal to participate
- Lack of informed consent by the patient or his family
About this study
Official title: Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia
The duration of treatment of community acquired pulmonary infection varies between 5 and 14 days according to the authors (22), or even 3 days with new drugs having long half-life (2). For nosocomial pulmonary infection, treatment durations are not standardized (5). It is simply mentioned the concept of "usual" treatment of at least 15 days. However, recent studies used 10 days of treatment without significant decrease in the rate of healing compared to usual treatment. It is essential to clarify the optimal duration of antibiotic treatment. Indeed, any excessive extension of treatment may increase the occurrence of adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and an increase in the cost of treatment
Read the detailed description
This is a prospective, randomized, open, multi-center study.
3.1 Primary Objective
Show that antibiotic therapy of 8 or 15 days is equivalent in terms of clinical cure rates in the treatment of early onset nosocomial pulmonary infection in patients under mechanical ventilation.
3.2 Secondary Objective
- Study of nosocomial infections: assessing the influence of the duration of antibiotic treatment on the rate of fatal pulmonary and extra-pulmonary infection (definition of nosocomial infections: annex XIII).
- Study of bacterial Ecology: research of changes in the flora of the gut under treatment and analysis of pathological samples (antibiotic resistance phenotypes +/-genotypes).
- Economic Survey: analyze the costs related to the treatment of nosocomial pneumonia and its complications in two study groups.
- Conditions
- Pneumonia Ventilator Associated
- Being tested
- Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin, compare 8 to15 days of antibiotic treatment
- Keywords
- Antibiotic, treatment, ventilator associated pneumonia, duration
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycinDrug
Also called Amoxicillin, Clavulanic acid
All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group.
- Beta-Lactams:
- Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS
- Ceftriaxone : 2 g OD during 3 days, then 1 g OD
- Cefotaxime : 2 g TDS during 3 days, then 1 g TDS
- Aminoglycosides
- Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
- Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure)
- Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
compare 8 to15 days of antibiotic treatmentDrug
Also called Amoxicillin, Clavulanic acid
All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group.
•
Beta-Lactams:
- Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS
- Ceftriaxone : 2 g OD during 3 days, then 1 g OD
- Cefotaxime : 2 g TDS during 3 days, then 1 g TDS
Aminoglycosides
- Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
- Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure)
- Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
| Study group | Role | What they receive |
|---|---|---|
| 8 days of antibiotic treatment | Experimental | Patients will receive a combination antibiotic during 5 days and then 3 days of a single Beta Lactam antibiotic Receives: Drug: Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin; Drug: compare 8 to15 days of antibiotic treatment |
| 15 days antibiotic treatment | Active comparator | All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for 10 days according to the group. The beta-lactam antibiotics will be administered in high doses during the first 3 days of treatment. Aminoglycosides will be administered in a single daily dose, with a loading dose the first day of treatment. Receives: Drug: compare 8 to15 days of antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of respiratory infection
The primary endpoint of the present study was the clinical cure rate at day 21. Complete clinical recovery was determined by the absence of the following criteria: death, septic shock (except when associated with a documented non-respiratory infection), intercurrent adverse event attributable to the protocol (or for which attributability to the protocol could not be ruled out) requiring modified antibiotic treatment, and patients who relapsed.
Measured: 21 days after inclusion
Secondary outcomes (1)
Rate of secondary infections
The study focused on establishing incidence of secondary nosocomial infections; number of patients on antibiotic treatment; total number of days of antibiotic treatment; duration of MV; number of patients still under ventilation; number of patients still in ICU; length of stay in ICU on day 21; and mortality rate at 3 months.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJan 1998
- Primary completionSep 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia Ventilator AssociatedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- French Society for Intensive Care, SmithKline Beecham, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Gilles R CAPELLIER, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559753
- Sponsor's protocol ID
- CHUB/GC001
- Status last verified
- Mar 2012
- First submitted
- 29 Nov 2011
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Capellier G, Mockly H, Charpentier C, Annane D, Blasco G, Desmettre T, Roch A, Faisy C, Cousson J, Limat S, Mercier M, Papazian L. Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment. PLoS One. 2012;7(8):e41290. doi: 10.1371/journal.pone.0041290. Epub 2012 Aug 31.
PubMed 22952580
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia
- ClinicalTrials.gov ID
- NCT01559753
- Acronym / sponsor ID
- CHUB/GC001
- Conditions
- Pneumonia Ventilator Associated
- Keywords
- Antibiotic, treatment, ventilator associated pneumonia, duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- French Society for Intensive Care, SmithKline Beecham, GlaxoSmithKline
- Study start
- Jan 1998
- Primary completion
- Sep 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 21 Mar 2012 (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 duration of treatment of community acquired pulmonary infection varies between 5 and 14 days according to the authors (22), or even 3 days with new drugs having long half-life (2). For nosocomial pulmonary infection, treatment durations are not standardized (5). It is simply mentioned the concept of "usual" treatment of at least 15 days. However, recent studies used 10 days of treatment without significant decrease in the rate of healing compared to usual treatment. It is essential to clarify the optimal duration of antibiotic treatment. Indeed, any excessive extension of treatment may increase the occurrence of adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and an increase in the cost of treatment
Detailed description
This is a prospective, randomized, open, multi-center study.
3.1 Primary Objective
Show that antibiotic therapy of 8 or 15 days is equivalent in terms of clinical cure rates in the treatment of early onset nosocomial pulmonary infection in patients under mechanical ventilation.
3.2 Secondary Objective
- Study of nosocomial infections: assessing the influence of the duration of antibiotic treatment on the rate of fatal pulmonary and extra-pulmonary infection (definition of nosocomial infections: annex XIII).
- Study of bacterial Ecology: research of changes in the flora of the gut under treatment and analysis of pathological samples (antibiotic resistance phenotypes +/-genotypes).
- Economic Survey: analyze the costs related to the treatment of nosocomial pneumonia and its complications in two study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 days of antibiotic treatment | Experimental | Drug: Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin, Drug: compare 8 to15 days of antibiotic treatmentPatients will receive a combination antibiotic during 5 days and then 3 days of a single Beta Lactam antibiotic |
| 15 days antibiotic treatment | Active comparator | Drug: compare 8 to15 days of antibiotic treatmentAll patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for 10 days according to the group. The beta-lactam antibiotics will be administered in high doses during the first 3 days of treatment. Aminoglycosides will be administered in a single daily dose, with a loading dose the first day of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early onset nosocomial pneumonia in patients under mechanical ventilation since at least 24 h Patients aged 18 years or more The patient must be able to receive either one of the two arms of treatment defined for the study Information on the patient and his family informed consent obtained during the first three days Bacteria sensitive to the specified antibiotic regimen
Key exclusion criteria (16 listed)
- Patients do not match the criteria for inclusion
- 18 years of age, pregnant Patients
- Another infectious outbreak documented the day of the BAL.
- Patients with acquired immunosuppression (blood diseases, HIV,...), induced (immunosuppressive drugs, cancer, radiation therapy) or congenital.
- Steroids for a period exceeding 15 days.
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 |
|---|---|---|
| Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycinAlso: Amoxicillin, Clavulanic acidAll patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group. * Beta-Lactams: * Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS * Ceftriaxone : 2 g OD during 3 days, then 1 g OD * Cefotaxime : 2 g TDS during 3 days, then 1 g TDS * Aminoglycosides * Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) * Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure) * Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) | Drug | 8 days of antibiotic treatment |
| compare 8 to15 days of antibiotic treatmentAlso: Amoxicillin, Clavulanic acidAll patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group. • Beta-Lactams: * Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS * Ceftriaxone : 2 g OD during 3 days, then 1 g OD * Cefotaxime : 2 g TDS during 3 days, then 1 g TDS Aminoglycosides * Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) * Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure) * Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) | Drug | 15 days antibiotic treatment, 8 days of antibiotic treatment |
Primary outcome
Cure of respiratory infection
Time frame: 21 days after inclusion
The primary endpoint of the present study was the clinical cure rate at day 21. Complete clinical recovery was determined by the absence of the following criteria: death, septic shock (except when associated with a documented non-respiratory infection), intercurrent adverse event attributable to the protocol (or for which attributability to the protocol could not be ruled out) requiring modified antibiotic treatment, and patients who relapsed.
1 secondary outcome
Rate of secondary infections
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Derived from this study: PubMed 22952580Capellier G, Mockly H, Charpentier C, Annane D, Blasco G, Desmettre T, Roch A, Faisy C, Cousson J, Limat S, Mercier M, Papazian L. Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment. PLoS One. 2012;7(8):e41290. doi: 10.1371/journal.pone.0041290. Epub 2012 Aug 31.
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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.
Gilles R CAPELLIER, MD, PhD principal investigator
Centre Hospitalier Universitaire de Besancon
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin and compare 8 to15 days of antibiotic treatment in people with Pneumonia Ventilator Associated, run by Centre Hospitalier Universitaire de Besancon.
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 16 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 21 Mar 2012. 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 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?
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?
Cure of respiratory infection (time frame: 21 days after inclusion). 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 NCT01559753, 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 21 Mar 2012.