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Trial Outcomes & Findings for Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers (NCT NCT01090141)

NCT ID: NCT01090141

Last Updated: 2020-11-27

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

0-24 Hrs

Results posted on

2020-11-27

Participant Flow

The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available

Participant milestones

Participant milestones
Measure
Subjects Recieving 100 mg of Micafungin
Micafungin: 100 mg IV infusion over 1 hour
Subjects Recieving 300 mg of Micafungin
Micafungin: 300 mg IV infusion over 1 hour
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 0-24 Hrs

Population: The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available

Outcome measures

Outcome data not reported

Adverse Events

Subjects Recieving 100 mg of Micafungin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Subjects Recieving 300 mg of Micafungin

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

Tawanda Gumbo

Unknown

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place