Mulago National Specialised Referral Hospital
Kampala, Uganda
Location contact
Haguma Coordinator, MD, MMed
CONTACT
Okwero Site Coordinator
CONTACT
Provia Ainembabazi
SUB_INVESTIGATOR
NCT Number: NCT07407868
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Kampala, Uganda
Haguma Coordinator, MD, MMed
CONTACT
Okwero Site Coordinator
CONTACT
Provia Ainembabazi
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At Admission;
At discharge
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 on sepsis, including danger signs.
Time frame: Day 90 post discharge
To determine the effect of EDI + IVR versus EDI alone on 90-day all-cause mortality after hospital discharge
Contact information is provided by the study sponsor or research team.
Castelnuovo Barbara Co-Chief Investigator, MD, PhD
CONTACT
Shevin Jacob Chief Investigator, MD, MPH
CONTACT
Makerere University
Other
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
Acronym: C4L-Sepsis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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