The comparison between short and long infusion of Ampicillin-Sulbactam in patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz.

The evaluation of clinical and laboratory efficacy of four-hour infusion vs. half-hour infusion of Ampicillin-Sulbactam in empiric and definite treatment of patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190425043368N1

Enrollment

136

Registered

2019-06-02

Start date

2019-05-22

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Condition 1: Severe Sepsis. Condition 2: Sepsis. Severe sepsis Sepsis, unspecified organism

Interventions

Intervention 1: Intervention group: Receiving Ampicillin-Sulbactam as a 4-hour infusion Patients receive 9 grams Ampicillin-Sulbactam every 8 hours, which is the therapeutic dose for resistant p

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: More than 18 years old Diagnosis of sepsis and severe sepsis based on qSOFA criteria Taking Ampicillin- Sulbactam at least for three days

Exclusion criteria

Exclusion criteria: Pregnancy Sensitivity to Ampicillin- Sulbactam Receiving Ampicillin- Sulbactam more than 24 hours during 1 week before being admitted to the intensive care unit Patients with GFR<10 ml/min or hemodialysis Patients with Pseudomonas, penicillin-resistant staph aureus (MRSA), or stenotrophomonas

Design outcomes

Primary

Measure	Time frame
Clinical cure (resolution of signs and symptoms related to the infection, including hypothermia or hyperthermia, low platelet count, high heart rate, high respiratory rate or low PaCO2, abnormal white blood cell count and positive microbial culture. Timepoint: At the end of therapy and 14 days after cessation of antibiotic. Method of measurement: Individual examination, measuring temperature by thermometer, complete blood count and determination of platelet and white blood cell count, measurement of heart rate and respiratory rate, analysis of blood gases, microbial culture.	—

Measure

Time frame

Clinical cure (resolution of signs and symptoms related to the infection, including hypothermia or hyperthermia, low platelet count, high heart rate, high respiratory rate or low PaCO2, abnormal white blood cell count and positive microbial culture. Timepoint: At the end of therapy and 14 days after cessation of antibiotic. Method of measurement: Individual examination, measuring temperature by thermometer, complete blood count and determination of platelet and white blood cell count, measurement of heart rate and respiratory rate, analysis of blood gases, microbial culture.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtabalsadat Mirjalili

Shiraz University of Medical Sciences

mahtab.mirjalili@gmail.com+98 71 3242 4127

Outcome results

None listed

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