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, Czechia83 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 range3 Months – 17 Years

SexALL

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)
✓. Physical Findings consistent with intra-abdominal infection, such as:
✓. Intention to send specimens from the surgical intervention for culture
✓. (Optional) Supportive radiologic findings of intra-abdominal infection, such as perforated intraperitoneal abscess detected on: Computed tomography (CT) scan or Magnetic resonance imaging (MRI) or Ultrasound (ii) Intra-operative/postoperative enrolment inclusion(in cases of postoperative enrolment, must be within 24 hours after the time of incision)::

Exclusion criteria

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)

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

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 range3 Months – 17 Years

SexALL

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)
✓. Physical Findings consistent with intra-abdominal infection, such as:
✓. Intention to send specimens from the surgical intervention for culture
✓. (Optional) Supportive radiologic findings of intra-abdominal infection, such as perforated intraperitoneal abscess detected on: Computed tomography (CT) scan or Magnetic resonance imaging (MRI) or Ultrasound (ii) Intra-operative/postoperative enrolment inclusion(in cases of postoperative enrolment, must be within 24 hours after the time of incision)::