Who is sponsoring NCT02285075?

NCT02285075 is sponsored by AZ Sint-Jan AV.

What condition does NCT02285075 study?

NCT02285075 studies Gram-Negative Bacterial Infections, Renal Failure Chronic Requiring Hemodialysis.

What drugs are being tested in NCT02285075?

Interventions: temocillin PK/PD in haemodialysis.

What is the status of NCT02285075?

NCT02285075 is currently COMPLETED.

Last reviewed 2016-01-03 · How we verify

A Clinical Pharmacokinetic Study: Is Three Times Weekly Temocillin Appropriate for the Treatment of Severe Gram-negative Infections in Patients With ESRD Treated With Intermittent Hemodialysis?

NCT02285075 Phase 4 COMPLETED

The current study aimed to explore the pharmacokinetics of temocillin in patients treated with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained with a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these doses given after haemodialysis sessions only.

Details

Lead sponsor	AZ Sint-Jan AV
Phase	Phase 4
Status	COMPLETED
Enrolment	16
Start date	2011-06
Completion	2014-12

Conditions

Gram-Negative Bacterial Infections
Renal Failure Chronic Requiring Hemodialysis

Interventions

temocillin PK/PD in haemodialysis

Primary outcomes

% of the dosing interval time above an MIC of 8 and 16 mg/L (% T>MIC 8 or 16 mg/L) — two to ten days
Is T \> MIC 8 and 16 mg/ML \> 40 or 60 %

Countries

Belgium