CompletedPhase 2

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

United States, Czechia, Greece83 participantsStarted 2015-08-01

Plain-language summary

This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam and metronidazole versus meropenem in paediatric population (from 3 months to less than 18 years of age )with complicated intra-abdominal infections (cIAIs)

Who can participate

Age range

3 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must be ≥3 calendar months to \<18 years of age. Patients aged ≥3 calendar months to \<1 year must have been born at term (defined as gestational age ≥37 weeks).
. Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from patient (if age appropriate according to local regulations)
. If female and has reached menarche, or has reached Tanner stage 3 development (even if not having reached menarche) (refer to Appendix E for further details on Tanner staging), the patient is authorised to participate in this clinical study if the following criteria are met:
. Requires surgical intervention that is expected to be completed within 24 hours of enrolment Laparotomy, laparoscopy, or percutaneous drainage
. Evidence of a systemic inflammatory response (at least 1): Fever (defined as oral temperature \>38.5°C, or equivalent to method used) or hypothermia (with a core body or rectal temperature \<35°C, or equivalent to method used) Elevated white blood cells (WBC) (\>15000 cells/mm3) C-reactive protein (CRP) levels (\>10 mg/L)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)

Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)

Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)

Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Trial details

NCT IDNCT02475733

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-01

Results submitted2018-07-12

View on ClinicalTrials.gov More Complicated Intra-abdominal Infections trials

Who can participate

Age range

3 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must be ≥3 calendar months to \<18 years of age. Patients aged ≥3 calendar months to \<1 year must have been born at term (defined as gestational age ≥37 weeks).
. Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from patient (if age appropriate according to local regulations)
. If female and has reached menarche, or has reached Tanner stage 3 development (even if not having reached menarche) (refer to Appendix E for further details on Tanner staging), the patient is authorised to participate in this clinical study if the following criteria are met:
. Requires surgical intervention that is expected to be completed within 24 hours of enrolment Laparotomy, laparoscopy, or percutaneous drainage
. Evidence of a systemic inflammatory response (at least 1): Fever (defined as oral temperature \>38.5°C, or equivalent to method used) or hypothermia (with a core body or rectal temperature \<35°C, or equivalent to method used) Elevated white blood cells (WBC) (\>15000 cells/mm3) C-reactive protein (CRP) levels (\>10 mg/L)