Trial Outcomes & Findings for Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD) (NCT NCT01401023)

Results Overview

Serum levels of tigecycline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

day 3 of treatment

Results posted on

2018-07-10

Participant Flow

Subjects were inpatients (Sparrow Hospital) with Clostridium difficile who were treated with tigecycline. Referral base was infectious disease consultations. The first patient was enrolled 11-23-2011 and the last 9-13-2012.

Participant milestones

Participant milestones
Measure	Clostridium Difficile Patient Open non-comparative trial Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDAD Patient n=10 Participants Open non-comparative trial Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=10 Participants
Age, Categorical >=65 years	3 Participants n=10 Participants
Age, Continuous	63 years STANDARD_DEVIATION 16 • n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: day 3 of treatment

Serum levels of tigecycline

Outcome measures

Outcome measures
Measure	Clostridium Difficile Patient n=10 Participants Open non-comparative trial Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile	0.18 milligrams/liter Standard Deviation 0.14

PRIMARY outcome

Timeframe: day 1 stool sample

Outcome measures

Outcome measures
Measure	Clostridium Difficile Patient n=10 Participants Open non-comparative trial Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates	0.15 milligram/liter Standard Deviation 0.06

PRIMARY outcome

Timeframe: day 3 of tigecycline therapy

Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.

Outcome measures

Outcome measures
Measure	Clostridium Difficile Patient n=10 Participants Open non-comparative trial Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Mean (SD) Serum Tigecycline Concentration Level	0.18 milligram/liter Standard Deviation 0.14

PRIMARY outcome

Timeframe: day 3 of tigecycline therapy

Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay

Outcome measures

Outcome measures
Measure	Clostridium Difficile Patient n=10 Participants Open non-comparative trial Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Mean (SD) Stool Tigecycline Concentration Level	17.8 micrograms/gram Standard Deviation 23.8

PRIMARY outcome

Timeframe: day 3 of treatment

Stool levels of tigecycline

Outcome measures

Outcome measures
Measure	Clostridium Difficile Patient n=10 Participants Open non-comparative trial Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile	17.8 micrograms/gram Standard Deviation 23.8

Adverse Events

CDAD Patient

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CDAD Patient n=10 participants at risk Open non-comparative trial Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Gastrointestinal disorders Recurrence of Clostridium difficile infection	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	CDAD Patient n=10 participants at risk Open non-comparative trial Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2

Additional Information

Dr. Gary Stein, Pharm D

Michigan State University

Phone: 517-353-5126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place