Trials / Completed
CompletedNCT03721302
NeoAMR Observational Study in Neonatal Sepsis
A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,202 (actual)
- Sponsor
- Drugs for Neglected Diseases · Academic / Other
- Sex
- All
- Age
- 60 Days
- Healthy volunteers
- Not accepted
Summary
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).
Detailed description
1. NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally. 2. NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Main study clinical sepsis | No intervention-Observational study |
| OTHER | Microbiology sub study | Analysis of Bacterial isolates |
Timeline
- Start date
- 2018-08-16
- Primary completion
- 2019-12-31
- Completion
- 2020-02-29
- First posted
- 2018-10-26
- Last updated
- 2020-08-19
Locations
19 sites across 11 countries: Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, Vietnam
Source: ClinicalTrials.gov record NCT03721302. Inclusion in this directory is not an endorsement.