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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07407868
Eligibility Criteria:
Inclusion Criteria:
* At admission
1. Adults ≥18 years.
2. Participant's hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components (signs of infection plus signs of severity/organ dysfunction):
1. Signs of infection: Suspected or proven infection, as determined by the medical team in charge.
2. Illness severity: Decision of the medical team to admit the patient to an adult medical ward of the study hospital, according to clinical appraisal of the treating physician and applicable guidelines.
3. Participant/proxy is willing to have their medical records reviewed by the trial team and get daily follow-ups until the time of discharge and to be approached again by the study team for a second informed consent process towards the time of hospital discharge.
4. Evidence of a personally signed and dated informed consent form stating that the participant/proxy has been informed of, had opportunity to ask questions about and have consented to the initial study procedures that will be conducted during their hospitalization. At discharge
5. Patient has overcome the critically ill phase of their hospitalization and is, according to the non-study clinical team caring for the patient, expected to be discharged within the next 24 hours.
6. Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures.
7. Evidence of a personally signed and dated informed consent form stating that the participant has been informed of, had opportunity to ask questions about and have consented to all procedures that will be conducted at the time of and after their discharge, and alternatives and risks for the study.
8. The participant confirms that there is availability of mobile network coverage in their place of residence.
Exclusion Criteria:
At Admission;
1. Patient who requires hospitalization for a condition that requires emergent or urgent obstetric or surgical intervention (including burns, trauma, abscess)
2. Persons who are currently or have been previously enrolled into this study.
3. Patient is terminally ill due to an underlying condition other than sepsis.
4. The patient is a detainee or prisoner.
5. The patient is unable to speak English and Luganda.
* At Discharge:
At discharge
6. The patient is unable to hear.
7. Participant states they will be unable to return to same health facility for the scheduled 14-day post-discharge clinic assessment (provided by the non-study clinical team)
8. Patients requiring clinical care for more than 10 days (if clinical care was completed and participant is ready for discharge but are still in hospital for financial or logistical reasons beyond 10 days, they can still be eligible)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07407868
Study Brief:
Protocol Section:
NCT07407868