Trial Outcomes & Findings for Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection (NCT NCT01951768)

Results Overview

Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

Approximately day 38

Results posted on

2019-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Garamycin Sponge (Gentamicin-Collagen Sponge) Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Systemic Antibiotic Systemic antibiotic therapy and standard ulcer care Systemic Antibiotic: Antibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Overall Study STARTED	43	45
Overall Study COMPLETED	43	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Garamycin Sponge (Gentamicin-Collagen Sponge) n=43 Participants Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Systemic Antibiotic n=45 Participants Systemic antibiotic therapy and standard ulcer care Systemic Antibiotic: Antibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Continuous	71 years STANDARD_DEVIATION 8 • n=5 Participants	72 years STANDARD_DEVIATION 8 • n=7 Participants	71 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Switzerland	43 participants n=5 Participants	45 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately day 38

Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection

Outcome measures

Outcome measures
Measure	Garamycin Sponge (Gentamicin-Collagen Sponge) n=43 Participants Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Systemic Antibiotic n=45 Participants Systemic antibiotic therapy and standard ulcer care Systemic Antibiotic: Antibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Clinical Cure	38 participants	39 participants

SECONDARY outcome

Timeframe: up to 38 days

Clinical significant improvement is defined as significant improvement of infection but not complete cure (e.g., residual uninfected skin lesions).

Outcome measures

Outcome measures
Measure	Garamycin Sponge (Gentamicin-Collagen Sponge) n=43 Participants Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Systemic Antibiotic n=45 Participants Systemic antibiotic therapy and standard ulcer care Systemic Antibiotic: Antibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Clinical Response	7 participants	13 participants

SECONDARY outcome

Timeframe: up to 38 days

Microbiological eradication of former infection

Outcome measures

Outcome measures
Measure	Garamycin Sponge (Gentamicin-Collagen Sponge) n=43 Participants Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Systemic Antibiotic n=45 Participants Systemic antibiotic therapy and standard ulcer care Systemic Antibiotic: Antibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Pathogen Eradication	26 participants	20 participants

Adverse Events

Garamycin Sponge (Gentamicin-Collagen Sponge)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systemic Antibiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. med. Ilker Uçkay

Geneva University Hospitals, Balgrist University Hospital

Phone: +41 44 386 11 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place