Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection (ART-CT001)
Clinical Assessment of the Safety and Efficacy of Artemisia Annua Infusion Preparation for the Treatment of Asymptomatic Plasmodium Falciparum Infection in Semi-immune Adults in Gabon
The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is:
Can Artemisia annua infusion be used to treat malaria?
Researchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion.
Participants will
- drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home
- visit the research centre once a week for three weeks after treatment for one month for safety reasons
연구 개요
상세 설명
For safety reasons, participants will be followed up daily for malaria-like symptoms and parasite counts until the end of treatment. Indeed, if they are not free of parasites after seven days of treatment, they will receive rescue treatment, which is the WHO-recommended malaria treatment.
Similarly, if the number of parasites in their blood increases or they develop malaria-like symptoms during treatment, they will receive rescue treatment.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Jean Claude Dejon Agobé, MD
- 전화번호: 0024177989191
- 이메일: jcagobe@cermel.org
연구 장소
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Gabon
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Lambaréné, Gabon, 가봉, BP: 242
- Centre de Recherches Médicales de Lambaréné
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연락하다:
- Jean Claude Dejon Agobé, MD, PhD
- 전화번호: 0024177989191
- 이메일: jcagobe@cermel.org
-
연락하다:
- Christian Chassem Lapue, MD
- 전화번호: 0024177989191
- 이메일: christian.chassem@cermel.org
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수석 연구원:
- Jean Claude Dejon Agobé, MD, PhD
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부수사관:
- Christian Chassem Lapue, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age: 18 to 45 years
- Absence of fever (body temperature <37.5ºC axillary or <38.0°C oral, rectal or tympanic temperature)
- Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood
- Have been living in an endemic area for at least 5 years.
- Written informed consent from the participant
- Residence in the vicinity of the study centre
- Willingness to comply with the follow-up schedule
Exclusion Criteria:
- History of fever over the last 72 hours
- Non-Plasmodium falciparum infection
- Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and/or after half-life time
- Presence of signs and symptoms related by the medical doctor to malaria
- Known history or evidence of clinically significant medical disorders
- Severe malnutrition
- Haemoglobin concentration <7 g/dL
- Known hypersensitivity and contraindications to any study medication
- Pregnancy or lactation
- Participation in other interventional studies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 컨트롤 암
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The research team will prepare one litre of 'Herba Centaurii' infusion every morning, which will be given to the participants in three splits every 8 hours, under the supervision of the research team for seven consecutive days.
다른 이름들:
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실험적: Artemisia arm
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Dried Artemisia annua leaves will be used to prepare an infusion by adding 5 mg of dried leaves to 1 litre of boiled water.
The mixture will be left to stand for 15 minutes, then stirred and strained before being administered to the participant.
Participants will receive 1 litre of this infusion (prepared each morning) per day for seven consecutive days.
The research team will administer the daily dose in three splits at 8-hour intervals.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants in whom the parasitaemia was cleared
기간: On day 7 from the first day of treatment
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No parasites detected in the thick blood smear (microscopic method)
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On day 7 from the first day of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants cured
기간: From the last day of treatment (day 7) to the end of the follow-up period on day 28
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Defined as the absence of Plasmodium infection (including reinfections) following treatment, as determined by microscopy and adjusted by PCR, in the per-protocol and intention-to-treat populations.
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From the last day of treatment (day 7) to the end of the follow-up period on day 28
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Number of adverse events
기간: From the first day of treatment (enrolment) to the end of the treatment period on day 7
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Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety
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From the first day of treatment (enrolment) to the end of the treatment period on day 7
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공동 작업자 및 조사자
수사관
- 연구 의자: Steffen Borrmann, Prof., Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany
- 연구 의자: Ayôla Akim Adegnika, Prof., Centre de Recherches Médicales de Lambaréné
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- SRC-2024-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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