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A Phase IIb, Randomized, blinded, parallel, placebo control, Explor the Efficacy of different doses of naphthoquine-azithromycin compounded formulation for malaria prevention

A Phase IIb, Randomized, blinded, parallel, placebo control, Explor the Efficacy of different doses of naphthoquine-azithromycin compounded formulation for malaria prevention

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020140
Enrollment
Unknown
Registered
2018-12-16
Start date
2009-10-08
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Group 1:A naphthoquine-azithromycin compounded formulation(400mg)
Group 2:A naphthoquine-azithromycin compounded formulation(800mg)

Sponsors

Yunnan Institute of Parasitic Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) All subjects voluntarily signed informed consents before the trial; (2) Ranged in age from 5–65 years-of-age male or female; (3) Subjects with no medical history or otherwise physically healthy; (4) Fertile woman pregnancy tests should be negative; (5) With 1 month prior to the screening were not participating in another trial.

Exclusion criteria

Exclusion criteria: (1) In the screening period had malaria symptoms or were positive for Plasmodium parasites according to a blood smear; (2) had a history of malaria in past two weeks; (3) had received antimalarial therapy in the past two weeks; (4) had received malaria prophylaxis in the past three months; (5) had a known or suspected allergy to macrolides, naphthoquine, or other product components; (6) had known or suspected liver and kidney dysfunction; (7) known or suspected poor compliance; (8) pregnant or lactating women; (9) had another disease(s) that might affect the assessment of therapeutic efficacy.

Design outcomes

Primary

MeasureTime frame
Protection rate;

Secondary

MeasureTime frame
Median time and mean time for smear positive;Total Positive rate of blood smear;Total Positive rate of blood smear;Cumulative life-incidence and otal Positive rate of blood smea;

Countries

China

Contacts

Public ContactHenglin Yang

Yunnan Institute of Parasitic Diseases

yanghenglin2014@126.com+86 0879-2141507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026