PneumoniaNCT02728518
Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia
A study testing Nebulized Amikacin and Intravenous Amikacin in people with Pneumonia, run by National Heart Institute, Egypt.
Trial summary
The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Nebulized Amikacin and Intravenous Amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2015
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ICU
- Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:
- purulent tracheal aspirations, or
- temperature of 38° or higher, or leucocyte count > 10000/ml or
- Positive culture sensitive to amikacin
- In case of empirical treatment, risk of multi resistant bacteria defined as follows:
- Antimicrobial therapy in preceding 90 days and
- Current hospitalization of 5 d or more
Who cannot join
- History of Asthma
- Multi organ failure or any psychiatric illness
- allergy to amikacin or intolerance to nebulized amikacin
- Myasthenia gravis.
- Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)
- Vestibulo-cochlear disease.
- Pregnancy.
- Brain death
About this study
Official title: Evaluation of the Safety and Efficacy of Nebulized Amikacin as Adjunctive Therapy in Hospital Acquired and Ventilator Associated Bacterial Pneumonia in Surgical Intensive Care Units
The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli
Read the detailed description
prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.
- Conditions
- Pneumonia
- Being tested
- Nebulized Amikacin, Intravenous Amikacin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized AmikacinDrug
400mg twice daily nebulized amikacin
Intravenous AmikacinDrug
20mg/kg once daily intravenous amikacin
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Amikacin | Experimental | patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam Receives: Drug: Nebulized Amikacin |
| Amikacin Intravenous | Active comparator | patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam Receives: Drug: Intravenous Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group
Measured: through study completion, over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NKhalek, National Heart Institute, Egypt
- Investigators
- Nehal A Hassan, BCPS, Principal investigator, National Heart InstituteFaten F El sayed, MD, Principal investigator, National Heart InstituteNirmeen A Sabry, Ph.D, Principal investigator, Faculty of Pharmacy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728518
- Sponsor's protocol ID
- NHI-01
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Nebulized Amikacin as Adjunctive Therapy in Hospital Acquired and Ventilator Associated Bacterial Pneumonia in Surgical Intensive Care Units
- ClinicalTrials.gov ID
- NCT02728518
- Acronym / sponsor ID
- NHI-01
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- National Heart Institute, EgyptOther government
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Apr 2016 (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 investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli
Detailed description
prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Amikacin | Experimental | Drug: Nebulized Amikacinpatients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam |
| Amikacin Intravenous | Active comparator | Drug: Intravenous Amikacinpatients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients admitted to ICU
- Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:
- purulent tracheal aspirations, or
- temperature of 38° or higher, or leucocyte count > 10000/ml or
- Positive culture sensitive to amikacin
Key exclusion criteria (8 listed)
- History of Asthma
- Multi organ failure or any psychiatric illness
- allergy to amikacin or intolerance to nebulized amikacin
- Myasthenia gravis.
- Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)
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 |
|---|---|---|
| Nebulized Amikacin400mg twice daily nebulized amikacin | Drug | Nebulized Amikacin |
| Intravenous Amikacin20mg/kg once daily intravenous amikacin | Drug | Amikacin Intravenous |
Primary outcome
Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group
Time frame: through study completion, over one year
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 25 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Nehal A Hassan, BCPS principal investigator
National Heart Institute
Faten F El sayed, MD principal investigator
National Heart Institute
Nirmeen A Sabry, Ph.D principal investigator
Faculty of Pharmacy Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized Amikacin and Intravenous Amikacin in people with Pneumonia, run by National Heart Institute, Egypt.
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 8 inclusion and 8 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 25 Aug 2016. 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.
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?
Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group (time frame: through study completion, over one year). 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 25 Aug 2016.