Short Course Radical Cure of P. Vivax Malaria in Nepal

Malaria Clinical Trial

Official title:

Short Course Radical Cure of P.Vivax in Nepal- a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04079621
• Other study ID #: SIRIN
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 27, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Description:

Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite.

In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.

The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• P. falciparum and/or vivax infection

• Fever (axillary temperature =37.5°C) or history of fever in preceding 48 hours

• Age >1 years

• G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines

• Written informed consent

• Able to comply with all study procedures and timelines

Exclusion Criteria:

• General danger signs or symptoms of severe malaria

• Anaemia, defined as Hb <8g/dl

• Pregnant women as determined by Urine ß-HCG pregnancy test

• Breast feeding women

• Known hypersensitivity to any of the drugs given

• Regular use of drugs with haemolytic potential

• Blood transfusion within the last 4 months

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Malaria, Vivax
• Malaria,Falciparum

Intervention

Drug:
• primaquine
Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)

Locations

Country	Name	City	State
Nepal	Malakheti Hospital	Malakheti
Nepal	Tikapur Hospital	Tikapur

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients vomiting their medication within 1 hour of administration		1 h
Other	The proportion of patients vomiting any of their PQ doses during the supervised course		7 - 14days
Other	The proportion of adverse events and serious adverse events		6 month
Other	The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion		6 month
Other	Risk of greater than 25% fall in haemoglobin on any day of treatment		7-14days
Other	The incidence risk of an acute drop in Hb of >5g/dl during PQ treatment		7-14days
Primary	Incidence Risk of P. vivax relapse at month 6	The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.	6 months
Secondary	The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax		6 months
Secondary	The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum		6 month
Secondary	The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection		Day 28
Secondary	The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection		Day 28
Secondary	The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection		Day 28