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Efficacy and Safety of Generic Preparation of Meropenem in the Treatment of Moderate to Severe or Antimicrobial-Resistant Infections

Effectiveness of a Generic Meropenem (Mapenem®) versus an Original Meropenem in the Treatment of Serious Infections: A Multicenter Cohort Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
TCTR
Registry ID
TCTR20100000054
Enrollment
400
Registered
2011-05-05
Start date
2009-12-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

moderate to severe infections meropenem&#44

Interventions

patients who treat original meropenem
Treatment
original

Sponsors

Siam Pharmaceutical
Lead Sponsor
Buddhachinaraj Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) adult (≥18 years old), 2) had been hospitalized with serious infection, such as lower respiratory tract infection, necrotizing skin/soft tissue infections, nosocomial or health-care associated intraabdominal infections, bacteremia, or sepsis, 3) infection was caused by multi-drug resistant Gram negative bacilli, ESBL-producing Enterobacteriaceae, or mixed anaerobic/aerobic bacteria, and 4) had received either generic meropenem (Mapenem®) or original meropenem

Exclusion criteria

Exclusion criteria: patients with pregnancy or lactation and patients who had hypersensitivity to carbapenems

Design outcomes

Primary

MeasureTime frame
to compare clinical outcome of generic and meropenem treatment at day 3, 7, and 14 one year to compare clinical outcome of generic and meropenem treatment at day 3, 7, and 14

Secondary

MeasureTime frame
to compare safety of generic and meropenem treatment at day 3, 7, and 14 one year to compare safety of generic and meropenem treatment at day 3, 7, and 14

Countries

Thailand

Contacts

Public ContactSomboon Tansuphasawadikul

Buddhachinnaraj Hospital

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026