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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2006-005079-17-FR |
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Date of registration:
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12/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open-Label, Multicenter, Multinational Study to Assess the Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-Ventilated Patients with Nosocomial Pneumonia
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Scientific title:
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An Open-Label, Multicenter, Multinational Study to Assess the Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-Ventilated Patients with Nosocomial Pneumonia |
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Date of first enrolment:
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19/02/2007 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005079-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Males and non-pregnant, non-lactating females, 18 years of age or older. For females of child-bearing potential, one of the following medically acceptable contraceptive methods must be used:
a) Double-barrier methods of contraception (e.g. condoms plus spermicidal foam)
b) Intrauterine contraceptive device
c) Approved pharmaceutical contraceptive product (e.g. birth control pills or patches, longterm injectable or implantable hormonal contraceptive)
2. Intubated and mechanically-ventilated (patients who have had a tracheostomy may be considered as possible study participants)
3. Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph and presence of gram-negative organisms by gram stain of respiratory secretions (tracheal aspirate, BAL, mini-BAL, PBS) plus at least 2 of the following:
a) Fever, defined as an oral temperature of > 38.0°C (100.4°F) or a rectal/core temperature
> 39.0°C (102.2°F), or hypothermia, defined as a rectal/core body temperature of < 35.0°C (95.2°F)
b) Leukocyte count = 10,000/mm3 or = 4,500/mm3
c) New onset of purulent sputum production or respiratory secretions, or a change in the character of sputum
4. Expected to remain intubated and mechanically-ventilated for at least three days after the start of study treatment
5. Be willing and able to give informed consent. If the patient is unable, the patient’s LAR may provide written consent as approved by the IRB/IEC.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Primary lung cancer or another malignancy metastatic to the lungs
2. Known or suspected active tuberculosis, cystic fibrosis, AIDS, or Pneumocystis carinii pneumonia
3. Receiving immunosuppressive therapy, defined as chronic treatment with known
immunosuppressant medications (including chronic treatment with >10 mg/day of systemic prednisone or equivalent)
4. BMI = 30
5. Burns greater than 40% of total body surface area
6. Any known chronic liver disease
7. Known local or systemic hypersensitivity to amikacin or aminoglycosides
8. Diagnosis of end stage renal failure or currently on dialysis
9. Severe hypoxemia as defined by Screening PaO2/FiO2 < 200
10. Serum creatinine > 2 mg/dL
11. Screening serum albumin level < 2 g/dL
12. Neutropenia (Screening ANC < 103 neutrophils/cc)
13. Any use of amikacin by any route within seven days prior to start of study treatment
14. Is participating in or has participated in other investigational trials within the last 28 days prior to study treatment
15. Presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and follow-up could be completed.
16. Known respiratory colonization with amikacin-resistant gram negative rods. Amikacin resistance is defined as an MIC > 32 mcg/mL.
17. Community-acquired pneumonia
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Nosocomial Pneumonia
MedDRA version: 8.1
Level: LLT
Classification code 10052596
Term: Nosocomial pneumonia
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Intervention(s)
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Product Name: Amikacin solution for inhalation 125mg/mL
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Amikacin sulphate
CAS Number: 39831-55-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
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Primary Outcome(s)
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Main Objective: - To determine the pharmacokinetic (PK) profile of aerosolized amikacin administered via the PDDS Clinical in patients with nosocomial pneumonia caused by gram-negative organisms
- To evaluate the safety and tolerability of aerosolized amikacin administered via PDDS Clinical in patients with nosocomial pneumonia caused by gram-negative organisms
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Primary end point(s): Pharmacokinetic and Safety
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Secondary Objective:
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Secondary ID(s)
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06-IN-AK004
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/02/2007
Contact:
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