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임상시험 NCT07249996 (MINERVAL)은(는) Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI), 바이러스 감염, 코호트 연구에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Respiratory Infections in Young Children (MINERVAL) 1,088 관찰 연구

모집중
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임상시험 NCT07249996 (MINERVAL)은(는) Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI), 바이러스 감염, 코호트 연구에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2024년 5월 2일에 시작되어 1,088명의 참여자를 모집하고 있습니다. Eduardo Lopez -Medina이(가) 진행하며, 2031년 12월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 25일에 갱신되었습니다.
간단한 개요
The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. The main questions it aims to answer are:

How often do respiratory infections occur in children under two years old, and which viruses or bacteria cause them? Why do some children develop more severe infecti...

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상세한 설명
Respiratory tract infections (RTIs) remain one of the most common causes of illness and death in young children, despite advances in vaccination and health programs. In children under five years of age, RTIs cause significant morbidity, social costs, and long-term health consequences. The clinical spectrum of RTI ranges from mild upper infections to severe lower respiratory tract infections (LRTIs) such as bronchioli...더 보기
공식 제목

Respiratory Infections in Young Children in Colombia and Panamá: Epidemiology, Interactions, and Long-term Consequences.

질환명
Respiratory Tract Infections (RTI)Lower Respiratory Tract Infection (LRTI)바이러스 감염코호트 연구
기타 연구 식별자
  • MINERVAL
  • 103600
NCT 번호
실제 연구 시작일
2024-05-02
최신 업데이트 게시
2025-11-25
예상 연구 완료일
2031-12-30
계획된 등록 인원
1,088
연구종류
관찰연구
상태
모집중
키워드
Birth Cohort Study
Respiratory Tract Infection (RTI)
Children
시험군 / 개입
참가자 그룹/시험군개입/치료
• Newborns younger than 29 days of life, with or without pre-existing conditions
Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, do not intend to relocate outside of the study area, provide informed consent to participate in the study and are willing to authorize data and specimen collection, storage and analysis.
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
Incidence rate
The number and etiology of new cases of RTI and LRTI according to cumulative time at risk and month of occurrence, in children aged 0 to 2 years.
From enrollment, up to 2 years of age.
이차결과변수
결과변수측정값 설명시간 범위
Severity by pathogen
Frequency of children who develop RTI, and mild, moderate or severe LRTI, according to pathogen and maximum level of care (outpatient care, emergency room, hospital admission or intensive care) and oxygen support (none, nasal canula, non-invasive ventilation or mechanical ventilation) received by children with LRTI, according to pathogen
From enrollment, up to 2 years of age
Burden in in-patient and outpatient settings
Median Duration of symptoms, Hospitalization rates, Length of hospital stay, Use of medications, Antibiotic consumption, Lost workdays and daily activities due to illness
From recruitment, up to 2 years of age
Pneumococcal bacterial load and Host immune response
Disease severity according to pneumococcal bacterial loads and whole blood transcriptome analysis.
From recruitment, up to 2 years of age
참여 도우미
적격성 기준

연령대
어린이
참여 가능한 성별
전체
건강한 참가자 허용
  • Newborns younger than 29 days of life, with or without pre-existing conditions
  • Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, and do not intend to relocate outside of the study area, to ensure adherence to RTI and in-person visits.
  • Infants whose parent(s) or guardian(s) provide informed consent to participate in the study.
  • Infants whose parent(s) or guardian(s) are willing to authorize data and specimen collection, storage and analysis.

  • Infants born to a pregnant mother under 14 years of age (under Colombian law, pregnancies occurring in individuals younger than 14 years of age are legally presumed to result from sexual abuse).
Eduardo Lopez -Medina logoEduardo Lopez -Medina
Merck Sharp & Dohme LLC logo머크
연구 책임자
Eduardo Lopez -Medina, 의뢰자-연구자, Scientific Director, CEIP, Centro de Estudios en Infectogía Pediatrica
연구 대표 연락처
연락처: Eduardo Lopez-Medina, MD, MSc, +57 315 0467762, [email protected]
연락처: Rodrigo DeAntonio, MD, 203 9760 / 62059692, [email protected]
2 2개국에 임상시험 장소

Valle del Cauca Department

Centro de Estudios en Infectologia Pediatrica, CEIP, Cali, Valle del Cauca Department, Colombia
Diana Maria Davalos, MD, MPH, DrPH, 연락처, +573156129274, [email protected]
모집중
Cevaxin, Panama City, Panama
Gabrielle Britton, PhD, 연락처, +5072039360, [email protected]
모집중