Study to evaluate the effect of Aztreonam (ATM) and Avibactam (AVI) in pediatric participants in serious bacterial infections

Phase 2

Recruiting

• Conditions: Health Condition 1: K319- Disease of stomach and duodenum, unspecified

• Registration Number: CTRI/2023/06/053835
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

1. Participants =9 months to <18 years of age at Screening

a) Refer below for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Female (post-pubertal) participants must have a negative serum/urine pregnancy test (ß-hCG sensitivity =25 mIU/mL),

Disease Characteristics:

2. Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative

pathogens,

3. Require hospitalization and IV antibiotic treatment.

Male Participant Reproductive Inclusion Criteria:

Male participants are eligible to participate if they agree to the following requirements

during the intervention period and for at least 7 days after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s):

1. Refrain from donating sperm.

PLUS either:

2. Be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.

OR

3) Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.

Female Participant Reproductive Inclusion Criteria:

A female participant is eligible to participate if she is not pregnant or breastfeeding, and

at least 1 of the following conditions applies:

1) Is not a WOCBP (Woman of Childbearing Potential)

OR

2) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), as described below, during the intervention period and for at least 28 days after the last dose of study intervention, which

corresponds to the time needed to eliminate any reproductive safety risk of the study intervention(s). If a highly effective method that is user dependent is chosen, a second effective method of contraception, as described below, must

also be used. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

The investigator is responsible for review of medical history, menstrual history, and

recent sexual activity to decrease the risk for inclusion of a woman with an early

undetected pregnancy.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

2. Gram-negative species not expected to respond to ATM-AVI =14 days

3. Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at =7 days (males) or =28 days (females) after last ATM-AVI infusion.

HAP/VAP only

4. Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.

5. Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).

Prior and Concomitant Therapy.

6. Received >24 hours of systemic antibiotics (abx) for =48hr before randomization,

except if;

a. Failed systemic abx for >48hr.

b. Not taking protocol prohibited medications,

Prior/Concurrent Clinical Study Experience:

Previous administration with an investigational product (drug or vaccine) within 30 days(or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).Diagnostic Assessments:

7. CrCL =15 mL/min/1.73 m2 (eGFR calculation based on age).

8. Non-infectious related screening ALT or AST >3 x ULN, ALP >3 x ULN and/orTBili >2 x ULN ( > 3 x ULN for Gilbert’s syndrome),

Other Exclusions:

9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study & Design

• Study Type: Interventional
• Study Design: Not specified