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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02434952
Other study ID # 015NECHR
Secondary ID
Status Completed
Phase Phase 4
First received September 11, 2014
Last updated August 22, 2016
Start date October 2014

Study information

Verified date August 2016
Source Malaria Consortium
Contact n/a
Is FDA regulated No
Health authority Cambodia: Ministry of Health
Study type Interventional

Clinical Trial Summary

In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop in the mosquito so it will not be able to inject malaria back into people when it bites. The drug the investigators will use is called primaquine.

Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility Inclusion Criteria:

- Age = 1 year

- Presentation with a confirmed fever (= 38°C axilla or = 37.5°C aural) or history of fever in previous 48 hours +/- other clinical features of uncomplicated malaria

- Plasmodium falciparum monoinfection = 1 asexual form / 500 white blood cells

- Informed consent (written/verbal) provided by patient or relative/legal guardian

- Signed Assent form for children aged 12 to < 18 years

Exclusion Criteria:

- Clinical signs of severe malaria or danger signs

- Pregnant or breast feeding

- Unable or unwilling to take a pregnancy test (for women of child-bearing age)

- Women intending to become pregnant in the next 3 months

- Allergic to primaquine or DHA PP

- Patients taking drugs known to cause acute intravascular haemolytic anaemia (AIHA) in G6PD deficiency e.g. dapsone, nalidixic acid

- Patients on treatment for a significant illness e.g. HIV, tuberculosis (TB) treatment, steroids

- On drugs that could interfere with anti-malarial pharmacokinetics like antiretrovirals, cimetidine, ketoconazole, antiepileptic drugs, rifampicin

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dihydroartemisinin piperaquine (DHA PP)

Primaquine


Locations

Country Name City State
Cambodia Ratanakiri Provincial Hospital Ratanakiri

Sponsors (5)

Lead Sponsor Collaborator
Malaria Consortium Centers for Disease Control and Prevention, Institute Pasteur, Cambodia, National Centre for Parasitology, Entomology and Malaria Control, Cambodia, World Health Organization

Country where clinical trial is conducted

Cambodia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Haemoglobin concentration Compare haemoglobin concentrations in g/dL between the G6PD deficient arm given DHA PP plus primaquine, and the G6PD normal arm receiving the same regimen Day 7 Yes
Secondary Determine G6PD enzyme activity Quantitative G6PD testing among all participants using the G6PD enzyme assay from Trinity Biologicals, USA, yielding G6PD enzyme results in U/g Hb. Day 0 No
Secondary Assess usefulness of field adapted WHO haemoglobin colour card vs. Hemocue Comparison of quantitative (HemoCue, g/dL HB) and qualitative (WHO haemolglobin colour card) estimates of haemoglobin concentration Day 0 No
Secondary Assess usefulness of rapid test for G6PDd in predicting acute intravascular haemolysis Comparison of rapid G6PD test (AccessBio, USA) qualitative result against quantitative G6PD assay to determine predictive value for clinically significant haemolysis Day 0 No
Secondary Proportion patients with =25% change in haemoglobin as a marker of intravascular haemolysis Comparing across all 4 arms: proportion of all patients with fractional change in haemoglobin =25% from day 0 to day 7 Change from Day 0 to Day 7 Yes
Secondary Plasma haemoglobin concentration as a marker of intravascular haemolysis Comparing across all 4 arms: plasma haemoglobin concentration at day 7 Day 7 Yes
Secondary Urine colour change as a marker of intravascular haemolysis Change in urine colour grade from day 0 to day 7 (Hillmen, Hall et al. 2004) Change from Day 0 to Day 7 Yes
Secondary Fractional change in haemoglobin as a marker of intravascular haemolysis Comparing across all 4 arms: fractional change in haemoglobin on day 7 vs. day 0 Change from Day 0 to Day 7 Yes
Secondary Clearance rate of primaquine Primaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Half life of primaquine Primaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Primaquine volume of distribution Primaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Clearance rate of piperaquine Piperaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
Secondary Half life of piperaquine Piperaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
Secondary Piperaquine volume of distribution Piperaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
Secondary Peak plasma concentration (Cmax) of primaquine Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Peak plasma concentration (Cmax) of piperaquine Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
Secondary Time to primquine peak plasma concentration (Tmax) Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Time to piperaquine peak plasma concentration (Tmax) Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
Secondary Area under the plasma concentration versus time curve - primaquine Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ Day 0-7 No
Secondary Area under the plasma concentration versus time curve - piperaquine Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ Day 0-28 No
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