Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00579956
Eligibility Criteria:
Inclusion criteria (all criteria must be satisfied)
A. Community acquired sepsis, and melioidosis is suspected:
Suspected melioidosis (12): all of the following are defined as 'clinically probable' melioidosis
* A history of frequent contact with soil or surface water in the endemic area
* At least one of the following risk factors: diabetes mellitus, chronic renal failure or renal calculi, thalassaemia, aplastic anaemia or steroid abuse
* An illness compatible with melioidosis, including the presence of sepsis, acute pneumonia, acute pyelonephritis, septic arthritis, parotid disease or skin or soft tissue infection, or
* An evidence of intra-abdominal suppuration (hepatic or splenic abscesses) regardless of risk factors or exposure history
Sepsis: defined as patients who have Systemic Inflammatory Response Syndrome (SIRS) - two or more of the following, clinically ascribed to infection:
* Fever: temperature \>38°C or \<36°C
* Tachycardia: heart rate \>90 beats/min
* Tachypnoea:
1. Respiratory rate \>20 breaths/minute; or
2. PaCO2 \<32 mmHg; or
3. Mechanical ventilation
* White cell count \>12,000 cells/mL or \<4,000 cells/mL or \>10% band forms B. Age \> 14 years. C. Need hospitalisation and intravenous antibiotic administration. D. Willingness to participate in the study and written, informed consent obtained from the patient.
Exclusion Criteria (any one of the following):
A. Pregnant or lactating women. B. Known hypersensitivity to meropenem or ceftazidime. C. Previous isolate with known resistance to ceftazidime or meropenem. D. Patients not expected to remain in hospital for treatment. E. Patients with community-acquired sepsis with cultures positive for other organisms.
F. Patients treated with antibiotics active against B. pseudomallei (including ceftazidime, amoxicillin-clavulanate, meropenem) for this episode for greater than 24 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00579956
Study Brief:
Protocol Section:
NCT00579956