Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909502649249 Date of Approval: 30/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Inhaled Amikacin for Ventilator Associated Pneumonia (VAP)
Official scientific title The efficacy, safety, and feasibility of inhaled amikacin for the treatment of ventilator associated pneumonia in patients with renal impairment
Brief summary describing the background and objectives of the trial Ventilator associated pneumonia (VAP), is considered one of the most common nosocomial infections seen in the intensive care unit (ICU) in patients requiring mechanical ventilation. Treatment relies on optimal general support measures and parenteral antibiotics with activity against frequent pathogenic microorganisms including multi-resistant Gram-negative bacteria. However, this therapy may not be completely effective, as penetration in respiratory secretions is poor for some antibiotics that are effective in vitro. Direct delivery of antibiotics to the lower airway is appealing, as it could be possible to achieve effective antibiotic levels in the site of infection with low systemic toxicity. Two important pharmacodynamic properties of aminoglycosides are the post antibiotic effect (PAE) and concentration-dependent killing; the post antibiotic effect refers to the persistent suppression of bacterial growth that occurs after the drug has been removed in vitro or cleared by drug metabolism and excretion in vivo, and Concentration-dependent killing refers to the ability of higher concentrations of aminoglycosides to induce more rapid, and complete killing of the pathogen. Achieving optimal peak concentrations of aminoglycosides with standard dosing regimens can be difficult, since efforts must be made to avoid sustained elevated trough concentrations which can predispose to nephrotoxicity. The aim of this study is to assess the efficacy and safety of inhaled amikacin for the treatment of late onset ventilator associated pneumonia in patients with renal impairment.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/09/2019
Actual trial start date
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group inhaled Amikacin Amikacin in a dose of 15mg/kg will be diluted in 20ml of normal saline / hr 9 days Jet nebulizer operating continuously during both insufflation and expiration should be placed in the inspiratory limb, 15–40 cm upstream of the Y-piece.  heat and moisture exchangers present will be removed during nebulization, and active heated humidifier will be switched off during nebulization. Volume-controlled ventilation with constant low inspiratory flow will be and an end inspiratory pause. If such specific ventilator settings are not tolerated, sedation during nebulization should be used. Amikacin in a dose of 15mg/kg will be diluted in 20ml of normal saline. 23
Control Group IV Amikacin dose and frequency according to creat clearance 7 days IV amikacin in dose and frequency according to modified renal dosing of the patient according to his creat clearance calculated daily 5-7 mg/kg CrCl >90 mL/min and aged <60 yr: q8hr CrCl 60-90 mL/min OR aged ≥60 yr: q12hr CrCl 25-60 mL/min: q24hr CrCl 10-25 mL/min: q48hr CrCl <10 mL/min: q72hr 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mechanically ventilated patients with oral endotracheal tube or tracheostomy tube for more than 48h. The patient diagnosed as having VAP during his stay in the intensive care unit based on the CDC criteria for clinical diagnosis of VAP. All patients should have an impaired renal functions either chronic kidney disease defined as glomerular filtration rate less than 90ml/min or acute kidney injury based RIFLE criteria for the classification of acute kidney injury. Patients under age of 18 years. Pregnancy Extrapulmonary infection. Allergy to aminoglycosides. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/07/2018 Ethics Committee Faculty of Medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
Shamplion street Alexandria 21211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome response to antibiotic treatment Cure” of pneumonia or persisting pneumonia after 9 days
Secondary Outcome Days of ventilation. weaning from mechanical ventialtion or death
Secondary Outcome Development of severe sepsis or septic shock. during 9 days of treatment
Secondary Outcome Mortality 28 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospital Shamplioon street Alexandria 21211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ibrahim ElBitash street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Alexandria University shamplion street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Mohamed Ezzeldin ElSaadany 19 Russell close Kings Lynn 999999 United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elsaadany m_elsaadany12@alexmed.edu.eg 004407341927467 19 Russell close
City Postal code Country Position/Affiliation
Kings Lynn United Kingdom lecturer Faculty of medicine alexandria university Anaesthetic trainee East of England United Kingdom
Role Name Email Phone Street address
Public Enquiries Ahmed Ibrahim amibrahim00@gmail.com 00201110778295 Albitash street
City Postal code Country Position/Affiliation
Alexandria 21211 Egypt Assisstant lecturer Faculty of medicine alexandria university
Role Name Email Phone Street address
Scientific Enquiries Lamia Kandil lamia.kandil@pua.edu.eg 00201224071274 Somoha
City Postal code Country Position/Affiliation
Alexandria 21114 Egypt lecturer Faculty of Pharmacy Pharos University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary of the collected data Clinical Study Report,Informed Consent Form 6 month after finishing trial data can be requested from principle investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information