SepsisC4L-SepsisNCT07407868
Call for Life Sepsis
A study testing Interactive Voice Response system-Call for life IVR in people with Sepsis, run by Makerere University at 2 sites in Uganda.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Interactive Voice Response system-Call for life IVR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 2 sitesUganda
- Study dates
- 10 Jun 2026to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites, 2 recruiting
- Not yet recruiting
Mulago National Specialised Referral Hospital
Kampala
Okwero Site Coordinator, +256774015921, mokwero@idi.co.ug
Haguma Coordinator, MD, MMed, +256777272582, priscilla.haguma@walimu.org
- Recruiting
Masaka Regional Referral Hospital
Masaka
About this study
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
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)
Read more
*All participants will receive a feature phone.
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.
- Conditions
- Sepsis
- Being tested
- Interactive Voice Response system-Call for life IVR
- Keywords
- Reduce post discharge sepsis mortality,, Interactive Voice Response System,, Call for life - IVR
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Response system-Call for life IVROther
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Discharge Intervention (EDI) | No intervention | 1. A standardized form provided around the time of hospital discharge (within 24 hours) with detailed information including the clinical course during hospitalization, including description of management and laboratory and clinical findings, discharge diagnosis, and any recommendations and treatment at discharge. The form will include a recommendation for a scheduled follow-up visit with a non-study clinician at the health facility from which the participant was discharged within 14 days after hospital discharge. 2. Standardized information education communication (IEC) materials that include explanations and descriptions (e.g., pictorial depictions) of emergency signs for sepsis and key triggers for seeking care |
| EDI plus IVR tool ( EDI-CFL IVR) | Experimental | EDI at the time of discharge, plus IVR tool: Participants will be provided analog phones with loaded airtime pro-rated to 3 months and instructions on battery charging. Features will include:
1. Automated IVR using Call for Life for status checks and optional health information tips at day 0, 1, 2, 7 and every 7 days within the first 28 days, followed by every 14 days from day 29 to day 90.
2. Reminders at 24 hours (day 13) and 48 hours (day 12) prior to scheduled appointments.
3. Alerts mapped onto the dash board, the alerts may be due to missed clinic visit or symptoms reported by clients/participants. In case of a missed clinic, alert, the study clinician will inform the clinician in charge of client management to make a follow-up on the client who has missed a visit. In case of a symptom alert or report of symptoms requiring rapid follow-up, the study clinician gives medical advice to patients accordingly and this is documented in the system. Receives: Other: Interactive Voice Response system-Call for life IVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality by Day 90 post-discharge (binary; time-to-event)
To determine the effect of EDI + IVR versus EDI alone on 90-day all-cause mortality after hospital discharge
Measured: Day 90 post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Jun 2026
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivalda Macicame, MD, Principal investigator, National Institute of Health -MozambiqueUche Unigwe, MD, PhD, Principal investigator, University of Nigeria Teaching Hospital-NigeriaJohn Appiah Adabie, MD, PhD, Principal investigator, Komfo Akonye Teaching Hospital-Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407868
- Sponsor's protocol ID
- IDI-REC-2025-204
- Acronym
- C4L-Sepsis
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This needs teh TMG to decide and approval of Data sharing agreement by the Uganda National Council of Science and Technology
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07407868
- Acronym / sponsor ID
- C4L-Sepsis / IDI-REC-2025-204
- Conditions
- Sepsis
- Keywords
- Reduce post discharge sepsis mortality,, Interactive Voice Response System,, Call for life - IVR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
*All participants will receive a feature phone.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Discharge Intervention (EDI) | No intervention | –1. A standardized form provided around the time of hospital discharge (within 24 hours) with detailed information including the clinical course during hospitalization, including description of management and laboratory and clinical findings, discharge diagnosis, and any recommendations and treatment at discharge. The form will include a recommendation for a scheduled follow-up visit with a non-study clinician at the health facility from which the participant was discharged within 14 days after hospital discharge. 2. Standardized information education communication (IEC) materials that include explanations and descriptions (e.g., pictorial depictions) of emergency signs for sepsis and key triggers for seeking care |
| EDI plus IVR tool ( EDI-CFL IVR) | Experimental | Other: Interactive Voice Response system-Call for life IVREDI at the time of discharge, plus IVR tool: Participants will be provided analog phones with loaded airtime pro-rated to 3 months and instructions on battery charging. Features will include: 1. Automated IVR using Call for Life for status checks and optional health information tips at day 0, 1, 2, 7 and every 7 days within the first 28 days, followed by every 14 days from day 29 to day 90. 2. Reminders at 24 hours (day 13) and 48 hours (day 12) prior to scheduled appointments. 3. Alerts mapped onto the dash board, the alerts may be due to missed clinic visit or symptoms reported by clients/participants. In case of a missed clinic, alert, the study clinician will inform the clinician in charge of client management to make a follow-up on the client who has missed a visit. In case of a symptom alert or report of symptoms requiring rapid follow-up, the study clinician gives medical advice to patients accordingly and this is documented in the system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At admission
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Voice Response system-Call for life IVRThe 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. | Other | EDI plus IVR tool ( EDI-CFL IVR) |
Primary outcome
All-cause mortality by Day 90 post-discharge (binary; time-to-event)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided. This needs teh TMG to decide and approval of Data sharing agreement by the Uganda National Council of Science and Technology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivalda Macicame, MD principal investigator
National Institute of Health -Mozambique
Uche Unigwe, MD, PhD principal investigator
University of Nigeria Teaching Hospital-Nigeria
John Appiah Adabie, MD, PhD principal investigator
Komfo Akonye Teaching Hospital-Ghana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Response system-Call for life IVR in people with Sepsis, run by Makerere University at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shevin Jacob Chief Investigator, MD, MPH (+1.206.4467075, Shevin.Jacob@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality by Day 90 post-discharge (binary; time-to-event) (time frame: Day 90 post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.