Treatment of severe malaria with injectable quinine

JRCT ID: jRCTs071180063

Registered date:19/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: malaria
• Date of first enrollment: 20/07/2017
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Treatment with un-licensed medicine

Outcome(s)

• Primary Outcome: survival rate

Secondary Outcome

1) Fever clearance time (h)
2) Parasite clearance time
3) Recrudescence before 28 days post-treatment

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Severe malaria patient, or malaria patient who cannot take oral antimalarial medicines for absolute contraindication or other reasons
2) Patient who gives written informed consent on his/her own free will to participate the above described study, after having fully understood the explanations on it
3) Patient whose legal representative gives written informed consent on his/her own free will to let the patient participate the above described study, after having fully understood the explanations on it

Exclude criteria

1) Patient who is allergic to quinine
2) Patient who refuses quinine injection
3) Patient principal investigator judged inappropriate

Related Information

• Primary Sponsor: Maruyama Haruhiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development(AMED)
• Secondary ID(s): UMIN000027485