Call for Life Sepsis

Official title

Evaluating The Impact on 90-day Survival Of Post-Discharge Follow-up Strategies Delivered To Adult Patients Hospitalized With Sepsis Across A Research Network In Sub-Saharan Africa

Overview

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis-attributable mortality in sub-Saharan Africa (sSA) is high, with in-hospital mortality in some settings approaching 40%. Studies show that mortality among children under 5 years hospitalized with sepsis remains high within the first 6 months of discharge. Additionally, high mortality has been observed among other populations within sSA, with factors such as HIV infection being associated with increased risk. Reducing sepsis deaths contributes to the achievement of the Sustainable Development Goals (SDG), particularly SDG 3 in reducing maternal mortality (3.1), neonatal and under five mortality (3.2), and burden of mortality from communicable diseases (3.3) and improving universal health coverage (3.8). The World Health Organization (WHO) has recognized sepsis as a global priority, with low- and middle-income settings being particularly affected. In sSA, sepsis is commonly associated with infectious diseases like malaria, Human Immunodeficiency Virus/ Acquired Immunodeficiency Syndrome (HIV/AIDS), pneumonia, tuberculosis, and diarrhea. Guidelines from the Surviving Sepsis Campaign (SSC) have become standard in some settings. However, little is known about patients' status post-discharge. This study aims to evaluate two post-discharge follow-up strategies for adult sepsis patients. Study duration is 45 months, participants will receive intervention up to 90 days post discharge. Description of intervention: Post-discharge follow-up strategy 1: Enhanced Discharge Intervention (EDI) Post-discharge follow-up strategy 2: EDI plus Interactive Voice Response (IVR) Objectives: The study aims to evaluate two post-discharge follow-up strategies for adult patients hospitalized with sepsis, focusing on their efficacy in reducing the 90-day mortality, and their effect on return to follow-up, number of re-admissions, and quality of life. Primary efficacy endpoint * 90- day all-cause mortality post discharge Secondary end points * Time to death * 28-day all-cause mortality * Attendance within 14-day check-up post discharge * Re-admission within 28 and 90 days * Days alive and out of hospital (DAOH) * Quality of life score (Baseline vs 28 day and Baseline vs 90 days) * Differences in baseline demographic and clinical characteristics (e.g., age, sex, disease severity, comorbidities, key laboratory values) between randomized participants and screen failures. Study design: This is an open-label, randomized, parallel, interventional study, with two post-discharge follow-up strategies: 1) EDI; or 2) EDI plus IVR system. Fixed allocation randomization at a 1:1 ratio will be applied to either study arm. Sample size: A total of 1,410 (705 per arm) from the four countries (Uganda, Nigeria, Ghana and Mozambique) will be enrolled competitively across the sites.

Interventions

• Other Interactive Voice Response system-Call for life IVR
  The CFL-Sepsis system will be developed for this trial to provide sepsis-related health information tips for adult patients who have recovered from a sepsis hospitalization. In this trial, the IVR will be used to reach out to the participants through a phone call. The purpose of the IVR will be to help the patient report on any symptoms that will need a clinician's advice, the system will help deliver status checks on participants' well-being and deliver general information and health education

Primary outcome measures

• All-cause mortality by Day 90 post-discharge (binary; time-to-event) [Time frame: Day 90 post discharge]

Eligibility criteria

Inclusion criteria

• At admission

• Adults ≥18 years.
• 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):

• Signs of infection: Suspected or proven infection, as determined by the medical team in charge.
• 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.
• 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.
• 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
• 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.
• Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures.
• 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.
• The participant confirms that there is availability of mobile network coverage in their place of residence.

Exclusion criteria

At Admission;

• Patient who requires hospitalization for a condition that requires emergent or urgent obstetric or surgical intervention (including burns, trauma, abscess)
• Persons who are currently or have been previously enrolled into this study.
• Patient is terminally ill due to an underlying condition other than sepsis.
• The patient is a detainee or prisoner.
• The patient is unable to speak English and Luganda.

• At Discharge:

At discharge

• The patient is unable to hear.
• 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)
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Uganda · 1 center

• Mulago National Specialised Referral Hospital — Kampala

Identifiers

NCT: NCT07407868 · IDI-REC-2025-204

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗