PneumoniaPhase 2NCT00786305
Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia
A Phase 2 study testing ceftazidime and amikacin in people with Pneumonia, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- ceftazidime and amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2004to Nov 2008
- 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
- Male or female >18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
- Written informed consent provided by the relatives
Who cannot join
- Pseudomonas aeruginosa resistant to ceftazidime and amikacin
- Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
- Severe septic shock and severe hypoxemia
- Allergy to ceftazidime or amikacin
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital
Paris, 75013
About this study
Official title: Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa
Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.
- Conditions
- Pneumonia
- Being tested
- ceftazidime and amikacin
- Keywords
- Nebulization, ceftazidime, amikacin, pneumonia, Pseudomonas aeruginosa, mechanical ventilation, Ventilator-associated pneumonia, treatment
- Medical subject headings
- Pneumonia, Pseudomonas Infections, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime and amikacinDrug
Also called fortum and amiklin
Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days
ceftazidime and amikacinDrug
Also called fortum and amiklin
Intravenous infusion of ceftazidime 30 mg/kg over 30 min followed by continuous infusion 90 mg/kg/day during 8 days and intravenous infusion of amikacin 15 mg/kg/day over 30 min during 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1: nebulized ceftazidime and amikacin | Experimental | Not described Receives: Drug: ceftazidime and amikacin |
| 2: intravenous ceftazidime and amikacin | Active comparator | Not described Receives: Drug: ceftazidime and amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial killing
Measured: 14 days
Secondary outcomes (1)
Changes of lung aeration
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startOct 2004
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Jacques Rouby, MD, PhD, Principal investigator, La Pitie-Salpetriere hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786305
- Sponsor's protocol ID
- NATB-2004
- Status last verified
- Nov 2008
- First submitted
- 5 Nov 2008
- Last updated
- 6 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT00786305
- Acronym / sponsor ID
- NATB-2004
- Conditions
- Pneumonia
- Keywords
- Nebulization, ceftazidime, amikacin, pneumonia, Pseudomonas aeruginosa, mechanical ventilation, Ventilator-associated pneumonia, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Nov 2008 (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.
Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: nebulized ceftazidime and amikacin | Experimental | Drug: ceftazidime and amikacin |
| 2: intravenous ceftazidime and amikacin | Active comparator | Drug: ceftazidime and amikacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female >18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
- Written informed consent provided by the relatives
Key exclusion criteria (4 listed)
- Pseudomonas aeruginosa resistant to ceftazidime and amikacin
- Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
- Severe septic shock and severe hypoxemia
- Allergy to ceftazidime or amikacin
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 |
|---|---|---|
| ceftazidime and amikacinAlso: fortum and amiklinNebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days | Drug | 1: nebulized ceftazidime and amikacin |
| ceftazidime and amikacinAlso: fortum and amiklinIntravenous infusion of ceftazidime 30 mg/kg over 30 min followed by continuous infusion 90 mg/kg/day during 8 days and intravenous infusion of amikacin 15 mg/kg/day over 30 min during 3 days | Drug | 2: intravenous ceftazidime and amikacin |
Primary outcome
Bacterial killing
Time frame: 14 days
1 secondary outcome
Changes of lung aeration
Time frame: 8 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 6 Nov 2008.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Jean-Jacques Rouby, MD, PhD principal investigator
La Pitie-Salpetriere hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ceftazidime and amikacin in people with Pneumonia, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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 2 inclusion and 4 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 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 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 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?
Bacterial killing (time frame: 14 days). 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 6 Nov 2008.