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Treatment of severe malaria with injectable artesunate (Injectable artesunate for malaria)

Treatment of severe malaria with intravenous quinine (Injectable artesunate for malaria)

Yamamoto Kei

Japan Institute for Health Security National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

yamamoto.k@jihs.go.jp

Yamamoto Kei

National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

+81-3-3201-7181

kyamamoto@hosp.ncgm.go.jp

Recruiting

June. 21, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients who have been confirmed to have malaria using one of the following methods, regardless of gender, nationality or race. In principle, all of the above patients will be targeted. Malaria will be diagnosed by identifying Plasmodium parasites using blood smear or flow cytometry with XN-31. Depending on the resources available at the clinical site, in cases where there is a high degree of urgency, diagnosis may be carried out by antigen detection using rapid diagnostic kits such as BinaxNOW malaria. However, a definitive diagnosis must be obtained by adding a subsequent examination of blood smears.

In case the results of the rapid kit and the smear test differ:
Although it is rare for the results of the rapid test kit and blood smear to differ, there is a possibility of a false positive result due to immunochromatographic assay. Conversely, the blood smear test may result in a false negative depending on the skill of the technician. If the results differ, consult with the principal investigator. If it is judged to be a false positive result, the patient will be excluded from the study.

2. Those who fall under any of the following criteria:
(1) Meet one or more of the following criteria and meet the criteria for severe malaria:
- Disturbance of consciousness or coma
- Convulsions
- Shock (systolic blood pressure below 90 mmHg)
- Hemoglobinuria
- Bleeding tendency
- Pulmonary edema (based on chest X-ray findings)
- Hypoglycemia (below 40 mg/dL)
- Metabolic acidosis (HCO3- below 15 mEq/L)
- Hyperlactatemia (above 5 mEq/L)
- Severe anemia (Hb below 8 g/dL)
- Plasmodium falciparum parasitemia (above 2 percent or 100,000 per microlite)
- Renal impairment (serum creatinine above 3.0 mg/dL)
(2) Patients with non-severe malaria who are unable to take oral antimalarial drugs such as quinine hydrochloride, atovaquone-proguanil combination tablets, mefloquine, or artemether-lumefantrine combination tablets.
(3) Patients who are contraindicated for oral antimalarial drugs.

3. Patients who fall under either of the following:
(1) Patients who can provide written consent for participation in this study in a manner appropriate to their age.
(2) If the study is initiated under the following circumstances, and the whereabouts of the substitute decision-maker are ultimately unknown:
- The research subject is in an emergency situation and there is a clear risk to their life.
- The research is unlikely to be sufficiently effective with normal medical treatment, but conducting the research has a high probability of saving the research subject's life.
- The burden and risk to the research subject caused by conducting the research is minimal.
- It is not possible to immediately contact the substitute decision maker.

1. Subjects with contraindications to use, such as a history of hypersensitivity to the drug or similar compounds
2. Subjects who refused to receive intravenous artesunate
3. Other subjects judged by the principal investigator to be unsuitable for the study

Both

malaria

Treatment with un-licensed medicine

in-hospital mortality rate

1) Fever clearance time (h) :The time when the body temperature first dropped below 37.5degrees Celsius, if the body temperature has been maintained below 37.5 degrees Celsius for 24 hours or more.
2) Parasite clearance time
3) Presence or absence of relapse up to 28 days after treatment
4) Occurrence of adverse events up to 28 days after treatment

+81-3-3202-7181

Feb. 21, 2025

No

none