Call for Life Sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses an Interactive Voice Response (IVR) system called Call for Life to support adults hospitalized with suspected or confirmed sepsis. Eligible participants are adults admitted with sepsis who consent to daily follow-up and a second consent at discharge. The trial aims to determine whether the IVR-based follow-up can lower mortality after discharge in sub-Saharan Africa, where sepsis mortality remains high. Methods involve hospital-based enrollment, daily post-discharge follow-up via the IVR program, and assessment of outcomes through medical records and patient contact. The study is led by Makerere University with sites at Mulago National Specialized Referral Hospital and Masaka Regional Referral Hospital in Uganda.

Why it matters

Who can join: the full rules

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)

Where it's running

• Masaka Regional Referral Hospital
  Masaka, Uganda Recruiting
• Mulago National Specialised Referral Hospital
  Kampala, Uganda Not yet recruiting

Study contacts

• Principal investigator: Ivalda Macicame, MD — National Institute of Health -Mozambique
• Study coordinator: Shevin Jacob Chief Investigator, MD, MPH
• Email: Shevin.Jacob@lstmed.ac.uk
• Phone: +1.206.4467075

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• Neutrophil EMR3 as a biomarker for sepsis in ICU patients

  Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07896018

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.