A Phase 2/3 interventional study of Chloroquine and Placebo in Malaria, sponsored by Centro de Investigacao em Saude de Manhica. Completed at 1 site in Mozambique. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Centro de Investigacao em Saude de Manhica · Phase 2/3, Interventional, and Prevention
One of the proposed ideas for malaria elimination includes the use of drugs to interrupt malaria transmission by exhausting the human reservoir of infection. Theoretically, mass treatment of an entire population with a very effective and rapid-acting drug (for instance an ACT), followed by the administration of an effective prophylactic regime during a minimum of four weeks, so as to outlast the typical development period of Plasmodium parasites in Anopheline mosquitoes, could achieve the same objective. In this respect, chloroquine (CQ) would be an appropriate candidate. This drug exhibits two conditions that make it attractive for elimination campaigns: 1) It has been demonstrated to have an excellent safety profile, allowing for its use in all age groups including pregnant women and children; and 2) Its relatively long elimination half life (t1/2=1-2 months) can provide a long post-treatment prophylactic effect. Recent evidence suggests that CQ sensitivity may be returning in places where discontinuation has reduced the drug pressure to the parasite populations. In countries such as Malawi, P. falciparum seems to have regained full sensitivity to CQ, and molecular markers of antiCQ resistance have nearly disappeared. While this does not support the reintroduction of CQ as first line therapy, it does suggest that, if proven sensitive in a given area, it could play a prophylactic role in malaria elimination strategies when used in combination with other drugs or tools. Thus, we intend to evaluate the potential role of chloroquine in preventing infections during elimination campaigns by performing a randomized, single-blind, placebo-controlled trial in asymptomatic Mozambican adults.
Choosing asymptomatic parasitaemic adult males from a malaria-endemic area as our study population introduces limited risks when administering a drug with an uncertain efficacy (47% efficacious in 2001-2002). In malaria-endemic areas, this age group has a remarkably low risk of developing severe disease (irrespective of clinical symptoms), and it is foreseeable that parasitemia may be well tolerated, and in certain cases, spontaneously cleared from the individual's blood as a result of the immune system. In the unlikely event of any clinical symptomatology appearing throughout the follow-up, individuals will be examined by a study clinician and treated immediately with the country's first-line malaria treatment (artemether-lumefantrine, Coartem ®).
This surveillance study is a two-arm prospective evaluation of parasitological responses to directly observed treatment with CQ (vs. placebo) for the clearing of asymptomatic parasitemia. People with asymptomatic P. falciparum parasitaemia, defined as the presence of a P. falciparum infection in the absence of any clinical symptomatology including fever, history of fever in the preceding 24 hours, malaise, fatigue, chills, or any other symptoms that may be derived from the malarial infection, who meet the study inclusion criteria will be enrolled, treated on site with CQ phosphate (25mg/Kg CQ base divided in three daily doses: 10mg/kg day 1 (usually 4 tablets); 10mg/kg day 2 (4 tablets) and 5mg/kg day 3 (2 tablets)) or placebo pills (same schedule, 4 tablets day one and two; and 2 tablets on day three), and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug. PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 75 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Centro de Investigacao em Saude de Manhica is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Chloroquine sulphate (Meriquine®; 250mg; 150 mg of chloroquine base; Baroda, India) will be administered at a total dose of 25 mg/kg (expressed as mg of CQ base per kg body weight, once daily during 3 consecutive days, following the schedule 10mg/kg Day 1; 10mg/kg day 2 and 5 mg/kg day 3).
Drug: Chloroquine
Placebo pills will be standard placebo capsules filled with powder contents with no pharmaceutical activity. They will not be identical to the chloroquine tablets, so the study will not be double blind, but rather single blinded. Placebo tablets will be manufactured by the pharmaceutical department of the Hospital Clínic, in Barcelona, Spain.
Drug: Placebo
Chloroquine sulphate (Meriquine®; 250mg; 150 mg of chloroquine base; Baroda, India) will be administered at a total dose of 25 mg/kg (expressed as mg of CQ base per kg body weight, once daily during 3 consecutive days, following the schedule 10mg/kg Day 1; 10mg/kg day 2 and 5 mg/kg day 3).
Also known as: Chloroquine Phosphate
Placebo Placebo pills will be standard placebo capsules filled with powder contents with no pharmaceutical activity. They will not be identical to the chloroquine tablets, so the study will not be double blind, but rather single blinded. Placebo tablets will be manufactured by the pharmaceutical department of the Hospital Clínic, in Barcelona, Spain
Also known as: Placebo capsules
Adequate parasitologic response (APR) to therapy
the absence of parasitemia at the end of the trial's follow-up period (Day 28), regardless of axillary temperature, without having previously met any of the criteria for early and late treatment failure
Time frame: 28 days after first day of drug intake
Early parasitologic failure
Detection of parasites once the initial parasitemia has been cleared in the time period from day 1 to day 3 after first day of drug intake
Time frame: 1-3 days after first day of drug intake
Late parasitologic failure
The detection of parasites in patients having cleared their initial parasitemia anytime from day 4 to day 28
Time frame: 4-28 days after first day of drug intake
Prevalence of chloroquine conferring pfcrt K76T mutation in pre-treatment infections
Proportion of the isolates detected with this specific mutation among isolates at baseline (before study drug initiation)
Time frame: 0 days after first day of drug intake
Rates of pre treatment pfcrt K76T mutation in cases of chloroquine treatment failure
Proportion of the isolates detected with this specific mutation at baseline among cases with confirmed treatment failure those
Time frame: 0 days after first day of drug intake
Rates of post treatment pfcrt K76T mutation in cases of chloroquine treatment failure
Proportion of the isolates detected as new infections or recrudescent ones with this specific mutation
Time frame: 28 days after first day of drug intake
Clearance time of parasitaemia
time in hours until the clearance of parasitemia
Time frame: 28 days after first day of drug intake
Plan to share: Undecided
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Centro de Investigacao em Saude de Manhica