COMBINE Combination Antibiotic Treatment for Resistant Bacterial Infections - Clinical Trial

What is the Purpose of this Study?

We are doing this study to help develop better antibiotic treatment plans for people with antibiotic-resistant bacterial infections. Antibiotic-resistant bacterial infections are hard to treat because they have the ability to overpower the drugs that were created to kill them.

We are studying the safety and effectiveness of two FDA approved antibiotics (Ceftazidime-Avibactam and Aztreonam) used together in combination.

What is the Condition Being Studied?

Antibiotic-resistant bacterial infections

Who Can Participate in the Study?

Healthy Adults, 18-45 who:
-Do not have a major disease or disorder
-Do not have a history of epilepsy or seizures
-Do not have HIV, hepatitis B or hepatitis C
-Have not smoked cigarettes or used nicotine products for the past 6 months
-Have not abused drugs or alcohol in the past 5 years
-Have not participated in an new drug study in the past 30 days
-Have not taken antibiotics, prescription medications, herbal or dietary supplements within 14 days of study enrollment

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

Have a screening visit that will last about 2 hours where you will:
--Have an electrocardiogram (ECG) where we will look at your heart
--Have blood taken
--Give a urine sample
--Have a physical exam

Once the screening visit is over and you are eligible, you will:
-Have an inpatient stay for 8 nights and 9 days in the Duke Early Phase Research Unit
-Receive a combination of the study antibiotics (ceftazidime-avibactam and aztreonam) which will be given in the vein every 6-8 hours for 7 days
-Have physical exams, vital signs, ECGs, blood draws and urine collections throughout your stay
-Have a follow-up visit 3-6 days after the inpatient stay

Study Details

Full Title
A Phase 1 Open Label Study in Healthy Adults to Evaluate the Safety and Pharmacokinetics of AVYCAZ® in Combination with Aztreonam (COMBINE) (DMID No. 17,0107)
Principal Investigator
Protocol Number
IRB: PRO00094792
NCT: NCT03978091
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698