임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07159373 (BOLT)은(는) 림프사상충증, 옴, 분선충증에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Better Options for Lymphatic Filariasis Treatment (BOLT) 3상 5,100 식이 요법 단일 투여
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07159373 (BOLT)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 림프사상충증, 옴, 분선충증에 대해 진행되며, 3상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 3월 1일부터 가능하며, 5,100명의 참여자를 모집할 예정입니다. Medicines Development for Global Health이(가) 진행하는 이 연구는 2028년 6월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 8일에 갱신되었습니다.
간단한 개요
The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are:
- Does MoxDA clear infection in people with lymphatic filariasis ?
- Does MoxDA caus...
공식 제목
Safety and Efficacy Trial of Mass Drug Administration With Moxidectin Versus Ivermectin in Combination With Diethylcarbamazine and Albendazole for Lymphatic Filariasis, Scabies, and Strongyloidiasis in Fiji
질환명
림프사상충증옴분선충증기타 연구 식별자
- BOLT
- MDGH-MOX-3003
NCT 번호
실제 연구 시작일
2026-03
최신 업데이트 게시
2025-09-08
예상 연구 완료일
2028-06
계획된 등록 인원
5,100
연구종류
중재연구
단계/상
3상
상태
대상자모집전
키워드
Moxidectin
Ivermectin
Mass drug administration
Lymphatic filariasis
Scabies
Strongyloidiasis
Cluster-randomized
Diethylcarbamazine
Albendazole
Ivermectin
Mass drug administration
Lymphatic filariasis
Scabies
Strongyloidiasis
Cluster-randomized
Diethylcarbamazine
Albendazole
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적MoxDA Moxidectin + diethylcarbamazine + albendazole | MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA).
Participants who are ineligible to receive moxidectin will be offered modified treatment options:
1. Children aged ≥ 2 years but \< 4 years - DEC, albendazole, and permethrin 5% cream
2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfe...더 보기 |
활성 대조군IDA Ivermectin + diethylcarbamazine + albendazole | IDA - Ivermectin + DEC + albendazole Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA).
Participants who are ineligible to receive moxidectin will be offered modified treatment options:
1. Children aged \< 2 years or weight \< 15 kg - DEC, albendazole, and permethrin 5% cream
2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breas...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA | Lymphatic filariasis (LF) Mf measured by ultrafiltration | 12 months post-treatment |
Incidence and severity of adverse events | Frequency, type, and severity of adverse events reported by treatment group | 7 days, 12 months and 24 months post-treatment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA | LF Mf measured using ultrafiltration | 24 months post-treatment |
Mean Mf density and mean change from Baseline at Months 12 and 24 following treatment with MoxDA or IDA in participants who are Mf-positive at Baseline | LF Mf measured using ultrafiltration | 12 and 24 months post-treatment |
Proportion of participants who are circulating filarial antigen (CFA)-positive at baseline who become CFA-negative at Months 12 and/or 24 following treatment with MoxDA or IDA | CFA measured using rapid lateral flow assay | 12 and 24 months post-treatment |
Change in community prevalence of LF, as measured by Mf, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 | LF Mf measured using ultrafiltration | 12 and 24 months post-treatment |
Change in community prevalence of LF, as measured by CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthl | CFA measured using rapid lateral flow assay | 12 and 24 months post-treatment |
Proportion of participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA | LF Mf measured using ultrafiltration | 12 to 24 months post-treatment |
Time to first detection of Mf in participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA | Lf Mf measured using ultrafiltration | 12 to 24 months post-treatment |
Community acceptability of MDA with MoxDA or IDA assessed by surveys, focus group discussions, and/or key informant interviews before Baseline and approximately 2 months following MDA at Baseline and Month 12 | Pre- and post-treatment at Baseline and post-treatment at Month 12 | |
Change in community prevalence of scabies and impetigo at Months 12 and 24 following annual community MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessment between Months 12 and 24 | Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin | 12 and 24 months post-treatment |
Change in community seroprevalence of S. stercoralis at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 | 12 and 24 months post-treatment | |
Change in community prevalence of LF, as measured by Mf and CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 | LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay | 12 and 24 months post-treatment |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
참여 가능한 성별
전체
건강한 참가자 허용
네
- Provision of signed and dated informed consent.
- Resident in one of the study locations.
There are no exclusion criteria to participation in the study.
Treatment Exclusion Criteria:
Participants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:
- Severe illness (any illness that is severe enough to interfere with activities of daily living);
- Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;
- Pregnant;
- Breastfeeding a baby within 7 days of birth;
- Age < 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or
- Age < 2 years or weight < 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).
Medicines Development for Global Health- Murdoch Childrens Research Institute
- Kirby Institute
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Ministry of Health and Medical Services Fiji, Suva, Fiji
Meciusela Tuicakau, MD, 연락처, +679 332 1500, [email protected]
Myra Hardy, MD, 책임연구자