Correlation of MTDH/AEG-1 and HOTAIR Expression with Metastasis and Response to Treatment in Sarcoma Patients.
Mohammed M Milhem, Tina Knutson, Shujie Yang...
https://pubmed.ncbi.nlm.nih.gov/23543869Actively Recruiting
Phase 2
Age: 18Years - 60Years
All Genders
ID07127718
Decreasing Leptospirosis Emergence Through Prognosis and Treatment Optimization (DeLEPTO) Project 1: Preventive Strategies for Early and Late Complications of Leptospirosis
Led by National Kidney and Transplant Institute, Philippines · Updated on 2026-04-13
678
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Kidney and Transplant Institute, Philippines
Lead Sponsor
S
San Lazaro Hospital, Philippines
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying leptospirosis, a bacterial infection, to understand if complement factor I (CFI) can predict lung complications and if treatments like plasma transfusion, hemoperfusion, and extracorporeal membrane oxygenation (ECMO) can help manage the disease and improve survival. This Phase 2 trial aims to find out whether these treatments reduce lung damage and mortality in patients with complicated leptospirosis. Participants may receive different treatments based on their assigned group: plasma transfusion involves receiving four plasma units over two days; hemoperfusion uses a device to filter harmful substances from the blood over at least three days; ECMO is provided if lung function worsens. All participants receive standard care such as antibiotics and fluids, and some may receive ECMO as rescue treatment depending on lung severity scores. During the study, participants give blood samples to measure CFI levels. Researchers monitor hospital stay length, lung and kidney complications, use of respiratory support, and survival for an average of three years. The study tracks various health measures including respiratory status, dialysis needs, and intensive care duration to evaluate treatment effects and safety throughout hospitalization and follow-up.
CONDITIONS
Brief Title
Preventive Strategies for Early and Late Complications of Leptospirosis
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Acute fever of 38°C for at least two days plus one symptom such as muscle pain, jaundice, headache, meningeal irritation, reduced urine, or eye redness
- Positive leptospirosis test by MAT, latex agglutination, IgG/IgM lateral flow, PCR, or blood culture without severe complications
- No need for ventilator support if in plasma transfusion groups
- Acute kidney injury requiring dialysis and vasopressor support with specific criteria if in hemoperfusion groups
- SOFA score less than 15 if in hemoperfusion groups
- Murray score of 2.75 or higher if eligible for ECMO
You will not qualify if you...
- History of chronic kidney disease or on maintenance dialysis
- Diseases causing lung bleeding like bronchiectasis
- Blood disorders, cancer, severe heart disease, HIV, tuberculosis with cavities, cirrhosis, or severe malnutrition (weight under 35kg)
- Recent cardiac arrest or Glasgow Coma Scale less than 8
- Pregnancy
- Need for emergency dialysis in plasma transfusion groups
- Significant lung problems or respiratory distress in plasma transfusion groups
- Severe neurological symptoms in plasma transfusion groups
- Low blood pressure or need for vasopressors in plasma transfusion groups
- Ongoing unstable blood circulation in plasma transfusion groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of hospital stay
Participants receive one of the following interventions based on their assigned group: prophylactic plasma transfusion administered intravenously over two consecutive days; hemoperfusion sessions lasting 2 to 2.5 hours repeated for at least three days; or conventional therapy including antibiotics and supportive care. Some participants may receive extracorporeal membrane oxygenation (ECMO) if clinical criteria are met during their hospital stay.
Daily visits during hospitalization
Follow-up
Duration - Up to 3 years
Participants are monitored after treatment completion for clinical outcomes including survival, pulmonary and renal function, and need for supportive therapies.
Periodic follow-up visits over up to 3 years
Trial Site Locations
Total: 3 locations
1
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila
Manila, National Capital Region, Philippines, 1000
Active, Not Recruiting
2
San Lazaro Hospital
Manila, National Capital Region, Philippines, 1003
Actively Recruiting
3
National Kidney and Transplant Institute
Quezon City, National Capital Region, Philippines, 1100
Actively Recruiting
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Research Team
R
Romina Danguilan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Clinical and pathophysiologic aspects of ECMO-associated hemorrhagic complications.
Konstantin A Popugaev, Sergey A Bakharev, Kirill V Kiselev...
https://pubmed.ncbi.nlm.nih.gov/33048966The effect of multidisciplinary extracorporeal membrane oxygenation team on clinical outcomes in patients with severe acute respiratory failure.
Soo Jin Na, Chi Ryang Chung, Hee Jung Choi...
https://pubmed.ncbi.nlm.nih.gov/29484504Position paper for the organization of extracorporeal membrane oxygenation programs for acute respiratory failure in adult patients.
Alain Combes, Daniel Brodie, Robert Bartlett...
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Richard Cheng, Rory Hachamovitch, Michelle Kittleson...
https://pubmed.ncbi.nlm.nih.gov/24210621Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation.
Nauman Khalid, Hasan Javed, Sarah Aftab Ahmad...
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Diego Pomarè Montin, Ghada Ankawi, Anna Lorenzin...
https://pubmed.ncbi.nlm.nih.gov/29886501Transfusion-associated circulatory overload and transfusion-related acute lung injury.
John W Semple, Johan Rebetz, Rick Kapur
https://pubmed.ncbi.nlm.nih.gov/30808638Transfusion-related acute lung injury: a clinical review.
Alexander P J Vlaar, Nicole P Juffermans
https://pubmed.ncbi.nlm.nih.gov/23642914