Evaluating the Role of Chloroquine for Malaria Elimination

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02698748
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Centro de Investigacao em Saude de Manhica
• Public title: Evaluating the Role of Chloroquine for Malaria Elimination Cloroquina
• Scientific title: Evaluating the Potential Role of Chloroquine in Preventing Infections During Elimination Campaigns: A Randomized, Single-blind, Placebo-controlled Trial in Asymptomatic Mozambican Adults
• Date of first enrolment: January 2015
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02698748
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 2/Phase 3

Countries of recruitment

Mozambique

Contacts

• Name: Pedro Aide, MD, MSc, PhD
• Affiliation: Centro de Investigação em Saude de Manhiça

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male individuals

- P. falciparum infection detected by microscopy (Minimum 250 parasites/microliter;
Maximum 10.000parasites/microliter)

- Ability to swallow oral medication

- Ability and willingness to comply with the study protocol for the duration of the
study and to comply with the study visit schedule; and

- Informed consent from the participant individual

Exclusion Criteria:

- Age <18 years

- Female individuals

- Axillary temperature >=37.5ºC

- Presence of any other co-existing clinical condition that in the opinion of the
recruiting physician would not allow the individual to be considered a "healthy"
asymptomatic carrier

- Regular medication which may interfere with antimalarial efficacy or antimalarial
pharmacokinetics, such as Cotrimoxazole

- History of hypersensitivity reactions or contraindications to CQ

- Known HIV positive patients in treatment with antiretrovirals



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Placebo

Drug: Chloroquine

Primary Outcome(s)

Adequate parasitologic response (APR) to therapy [Time Frame: 28 days after first day of drug intake]

Secondary Outcome(s)

Clearance time of parasitaemia [Time Frame: 28 days after first day of drug intake]

Early parasitologic failure [Time Frame: 1-3 days after first day of drug intake]

Rates of pre treatment pfcrt K76T mutation in cases of chloroquine treatment failure [Time Frame: 0 days after first day of drug intake]

Late parasitologic failure [Time Frame: 4-28 days after first day of drug intake]

Prevalence of chloroquine conferring pfcrt K76T mutation in pre-treatment infections [Time Frame: 0 days after first day of drug intake]

Rates of post treatment pfcrt K76T mutation in cases of chloroquine treatment failure [Time Frame: 28 days after first day of drug intake]

Secondary ID(s)

CNBS (173/CNBS/13)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors