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Clinical experience with ertapenem in acute pyelonephritis due to ESBL producing enterobacteriaceae in India

Clinical Experience with ertapenem in acute pyelonephritis due to ESBL producing enterobacteriaceae

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/05/004637
Enrollment
100
Registered
2014-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute pyelonephritis due to ESBL producing enterobacteriaceae

Interventions

Intervention1: Ertapenam: This study is an observational data collection process for the patients with acute pyelonephritis who have been treated earlier with ertapenam as per the routine standard cli

Sponsors

MSD Pharmaceuticals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ï??Age: â?§18 years ï??Diagnosis of Acute Pyelonephritis [i.e., patients with fever, flank pain or costvertebral angle tenderness, pyuria (>= 10 white blood cell per high power field)] and confirmed ESBL Enterobacteriaceae (as per CLSI, Vitek-2) on urine culture ï??Patient received Ertapenem therapy (>=3 dose)

Exclusion criteria

Exclusion criteria: ï??Need for concomitant antimicrobials in addition to study therapy ï??A history of coronary heart disease or stroke, serum Creatinine >1.5 mg/dl, albuminuria >40 μg/min, and use of lipid-lowering drugs, aspirin, or other antihypertensive agents.

Design outcomes

Primary

MeasureTime frame
The primary outcome measures include clinical response of Ertapenem in Acute Pyelonephritis due to ESBL-p Enterobacteriaceae.Timepoint: 10-14 days

Secondary

MeasureTime frame
ï?? Sub group analysis: Ertapenem as empiric &definitive; Response in ESBL-pE.coli ï?? Duration of Ertapenem treatment ï?? Clinical response of Ertapenem as OPAT therapy ï?? Mean bed days saved/patient under OPAT therapy ï?? Total no of days/duration of Ertapenem as OPAT therapy ï?? Cost comparison of Ertapenem under OPAT vs., inpatient settings. Timepoint: â?¢10-14 days â?¢10-14 days â?¢10-14 days â?¢on completion of the study â?¢on completion of the study â?¢on completion of the study

Countries

India

Contacts

Public ContactDrVRamasubramanian

Apollo Hospitals Enterprises limited

idisdoc@gmail.com9840078979

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026