Trial Outcomes & Findings for Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation (NCT NCT03721328)
NCT ID: NCT03721328
Last Updated: 2022-01-11
Results Overview
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
12 months
Results posted on
2022-01-11
Participant Flow
Participant milestones
| Measure |
Local Irrigation With Vancomycin + Tobramycin
Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Baseline characteristics by cohort
| Measure |
Experimental
n=15 Participants
Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation
|
|---|---|
|
Age, Continuous
|
69.27 Years
STANDARD_DEVIATION 7.329 • n=93 Participants
|
|
Age, Customized
<60 years
|
2 Participants
n=93 Participants
|
|
Age, Customized
>= 60 years
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
|
Affected Joint
Knee
|
14 Participants
n=93 Participants
|
|
Affected Joint
Hip
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Outcome measures
| Measure |
Experimental
n=15 Participants
Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation
|
|---|---|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
SAE Relationship to Study Treatment Procedure UNRELATED
|
7 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Any Adverse Event
|
14 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
AE Relationship to NPWT Device UNRELATED
|
14 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
AE Relationship to Study Medication UNRELATED
|
14 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
AE Relationship to Study Treatment Procedure UNRELATED
|
14 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Severity - Mild
|
14 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Severity - Moderate
|
7 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Severity - Severe
|
6 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Serious Adverse Event
|
7 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
SAE Relationship to NPWT Device UNRELATED
|
7 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
SAE Relationship to Study Medication UNRELATED
|
7 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Suspected Adverse Reaction
|
0 Participants
|
|
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Adverse Reactions
|
0 Participants
|
Adverse Events
Local Irrigation With Vancomycin + Tobramycin
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Local Irrigation With Vancomycin + Tobramycin
n=15 participants at risk
Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation
|
|---|---|
|
Cardiac disorders
Atrial Flutter
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Chest pain
|
13.3%
2/15 • 12 Months
|
|
Cardiac disorders
Pulmonary oedema
|
6.7%
1/15 • 12 Months
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Rotavirus infection
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
1/15 • 12 Months
|
|
Product Issues
Device loosening
|
6.7%
1/15 • 12 Months
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
6.7%
1/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • 12 Months
|
Other adverse events
| Measure |
Local Irrigation With Vancomycin + Tobramycin
n=15 participants at risk
Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • 12 Months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Cor pulmonale
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Myocardial ischaemia
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • 12 Months
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • 12 Months
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • 12 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 12 Months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • 12 Months
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 12 Months
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • 12 Months
|
|
General disorders
Chest pain
|
6.7%
1/15 • 12 Months
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • 12 Months
|
|
General disorders
Peripheral swelling
|
33.3%
5/15 • 12 Months
|
|
General disorders
Pyrexia
|
13.3%
2/15 • 12 Months
|
|
Immune system disorders
Drug hypersensitivity
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Arthritis infective
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Cystitis
|
13.3%
2/15 • 12 Months
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • 12 Months
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Stitch abscess
|
6.7%
1/15 • 12 Months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
53.3%
8/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Bone contusion
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Burns second degree
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
6.7%
1/15 • 12 Months
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
6.7%
1/15 • 12 Months
|
|
Investigations
Fungal test positive
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
6.7%
1/15 • 12 Months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.7%
1/15 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
6.7%
1/15 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
6.7%
1/15 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • 12 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
6.7%
1/15 • 12 Months
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 12 Months
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • 12 Months
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • 12 Months
|
|
Renal and urinary disorders
Urinary retention
|
13.3%
2/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
1/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • 12 Months
|
|
Surgical and medical procedures
Catheter placement
|
6.7%
1/15 • 12 Months
|
|
Surgical and medical procedures
Endodontic procedure
|
6.7%
1/15 • 12 Months
|
|
Surgical and medical procedures
Knee arthroplasty
|
6.7%
1/15 • 12 Months
|
|
Surgical and medical procedures
Wound drainage
|
6.7%
1/15 • 12 Months
|
|
Vascular disorders
Hypotension
|
26.7%
4/15 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place