Clinical trial NCT01746654: Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
Official title: A Randomized Double-Blind Placebo-Controlled Study to Determine Safety of P128 Applied to Nares of Healthy Volunteers and Safety And Efficacy of Any Patient Including Chronic Kidney Disease Patients Who Are Nasal Carriers of S.Aureus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infectious Disease
Bacterial Infections
Keywords: S.aureus
Methicillin Resistant S.aureus (MRSA)
Nasal carrier status
Prophylaxis
Lead sponsor: GangaGen, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus aureus) in humans.

Detailed description: Staphylococcus aureus with acquired multiple-drug resistance poses an increasing problem in both hospital and community settings. S. aureus is known to cause infections ranging in severity from skin infection to systemic bacteremia. As nasal colonization is the principal ecological niche for these bacteria and has been shown to be a significant risk factor in developing S. aureus infection, it is of importance to develop an efficient therapy that is able to clear this bacterium from human nostrils.

In-vivo studies have shown that P128 treatment is efficacious in reducing and decolonizing MRSA bacteria from rat nostrils.

Pre-clinical safety studies in animal models indicated no test drug related toxicity signs at the site of application or systemically.

The present clinical trial is conducted in four parts. Part A consists of safety and tolerability studies in 4 cohorts of 3 healthy subjects who are administered a single dose of three escalating concentrations of the drug and placebo intra-nasally. Part B consists of safety \& tolerability as in part A but with multiple doses (3 doses/day for 5 days). Part C comprises of safety/tolerability as well as efficacy studies in chronic kidney disease patients stable on dialysis who are nasal carriers of S.aureus or MRSA on a treatment regimen as in Part B. Part D comprises of safety and efficacy studies in any patient who are nasal carriers of S.aureus or MRSA with single dose of 3 escalating concentrations of the drug and placebo intra-nasally.

Eligibility criteria: Inclusion Criteria:

* Healthy human volunteer
* Any patient clinically stable who are nasal carrier of S. aureus or MRSA including Chronic Kidney disease patients stable on dialysis

Exclusion Criteria:

* Presence of active systemic bacterial infection of any nature not cured at least 4 weeks before enrollment.
* Systemic or intra-nasal anti-bacterial treatment during four week period before enrollment
* Pregnancy, breast feeding during the study duration
* Participation in any other intervention study during the past three months

Primary outcomes:
measure: Safety and tolerability (Part A, Part B, Part C and Part D); Efficacy (Part C and Part D)
timeFrame: 30 Days (Part A and Part B), 20 Days (Part C), 7 Days (Part D)
Secondary outcomes:
measure: Immunogenicity (Part A, Part B and Part C)
timeFrame: 8 Days (Part A), 13 Days (Part B)
measure: Pharmacokinetics (Part A and Part B)
timeFrame: 1 Day (Part A), 6 days (Part B)
measure: Secondary efficacy (Part C)
timeFrame: 3 days
measure: Re-colonization (Part C)
timeFrame: 14 Days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Dale A Fisher, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal Acunova Ltd, Bangalore
name: Surinder Kher, MD
role: STUDY_DIRECTOR
References: