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A study to see whether giving the broad spectrum antibiotic meropenem over 3 hours improves recovery in patients with serious blood infections instead of giving over 30 minutes

To compare and assess the clinical outcome in patients receiving meropenem as extended infusion versus intermittent bolus for gram negative bacteraemia susceptible to meropenem - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100560
Enrollment
100
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhere Health Condition 2: B961- Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere Health Condition 3: B965- Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere

Interventions

Intervention1: Meropenem extended infusion: Meropenem given as infusion over 3 hours upto 7 days Control Intervention1: Meropenem bolus: Meropenem given over 30 minutes upto 7 days

Sponsors

Armed Forces Medical College, Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with culture reports suggesting Gram Negative Bacteremia susceptible to Meropenem. Patients initiated on Meropenem therapy by the treating Physician. SOFA score 2 12

Exclusion criteria

Exclusion criteria: Pregnancy and lactation. Known allergies to Penicillin. Patients on any other antibiotic with similar spectrum as that of Meropenem

Design outcomes

Primary

MeasureTime frame
To compare the rate of complete resolution of leukocytosis (TLC less than 11,000/cumm) and rate of being afebrile (Temp below 99F for 24hrs) in patients with culture positive gram-negative bacteremia being treated with meropenem given as extended infusion versus intermittent dosingTimepoint: at the end of 07 days

Secondary

MeasureTime frame
To compare the time (in days) taken for clinical cure in both groupsTimepoint: ;To compare the mean change in SOFA scores in both groupsTimepoint: at the end of 7 days after the start of meropenem therapy;To compare the mean duration of hospital stay among both groups of patientsTimepoint: ;To compare the all-cause mortality rateTimepoint: at the end of 30 days

Countries

India

Contacts

Public ContactSiva Bhanu Prakash Prudhivi

Armed Forces Medical College, Pune

doctorweaver121@gmail.com9765088248

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026