NEWS HIGHLIGHTS
Published Studies Related to Primaquine
Methemoglobinemia and adverse events in Plasmodium vivax malaria patients associated with high doses of primaquine treatment. [2009.02]
Primaquine (PQ) is recommended to prevent relapses in patients with Plasmodium vivax malaria infection. However, treatment with PQ causes methemoglobinemia... We conclude that when PQ is administered under certain conditions (i.e., normal glucose-6-phosphate dehydrogenase activity, in non-pregnant subjects and with a light meal), daily doses as high as 1.17 mg/kg do not represent a serious risk of high MetHB levels to patients.
The efficacy and tolerability of three different regimens of tafenoquine versus primaquine for post-exposure prophylaxis of Plasmodium vivax malaria in the Southwest Pacific. [2008.11]
Tafenoquine is being developed for radical cure and post-exposure prophylaxis of Plasmodium vivax malaria. In an open-label study, 1512 Australian Defence Force personnel received one of three tafenoquine 3 d regimens [400 mg once daily (od), 200 mg twice daily (bid), 200 mg od] or daily primaquine (22.5 mg) plus doxycycline (100 mg) over 14 d in Bougainville and in Timor-Leste for post-exposure prophylaxis...
A Randomized Open-Label Trial of Artesunate- Sulfadoxine-Pyrimethamine with or without Primaquine for Elimination of Sub-Microscopic P. falciparum Parasitaemia and Gametocyte Carriage in Eastern Sudan. [2007.12.12]
CONCLUSION: Addition of primaquine to artemisinin combination treatment did not improve elimination of parasitaemia and prevention of gametocyte carriage in carriers with low-density parasitaemia in the dry season. TRIAL REGISTRATION: ClinicalTrials.gov NCT00330902.
Primaquine Clears Submicroscopic Plasmodium falciparum Gametocytes that Persist after Treatment with Sulphadoxine-Pyrimethamine and Artesunate. [2007.10.10]
CONCLUSIONS: PQ clears submicroscopic gametocytes after treatment with SP+AS and the persisting gametocytes circulated at densities that are unlikely to contribute to malaria transmission. For individuals without severe anaemia, addition of a single dose of PQ to an efficacious antimalarial drug combination is a safe approach to reduce malaria transmission following treatment. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN61534963.
Primaquine for preventing relapses in people with Plasmodium vivax malaria. [2007.01.24]
CONCLUSIONS: Primaquine (15 mg/kg/day for 14 days) plus chloroquine is more effective than chloroquine alone or primaquine (15 mg/kg for 5 days) plus chloroquine in preventing relapses of vivax malaria. Primaquine (five days) plus chloroquine appears no better than chloroquine. Countries should follow the WHO's recommendation for 14-day primaquine plus chloroquine regimen. Alternative regimens need to be evaluated in randomized controlled trials, which should also consider variations in regional P. vivax strains and the possibility of primaquine resistance, reinfection, and adherence in those who relapse.
Clinical Trials Related to Primaquine
Eight Week Primaquine Regimen for the Treatment of Vivax Malaria [Completed]
Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it
accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A
substantial proportion of clinical cases are not caused by infective bites of Anopheles spp,
but by activation of latent hypnozoites in the liver. These relapses may significantly impede
development since each illness may result in 5-15 days of absence from work or school.
Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is
beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in
the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing,
primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may
be a safe and effective alternative to the traditional 14 day course of the drug. The aim of
the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as
effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis
in G6PD deficient individuals.
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS [Completed]
A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS [Completed]
To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis
carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a
standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance
of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per
09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments
in patients who are intolerant to SMX/TMP.
The type of treatment being studied has the advantages of wide applicability throughout the
world (including developing countries) and low cost. An oral treatment is more accessible to
patients than drugs given by injection or by inhalation.
Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan [Completed]
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose
parasitaemia persists at very low levels throughout the dry season, could be a useful
strategy for malaria control in areas with a short transmission season. We did a randomized
trial to compare two regimens for clearance of low level parasitaemia in the dry season.
Mass-Drug Administration to Reduce Malaria Transmission [Active, not recruiting]
In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a
tool for malaria control in 'exceptional conditions when conventional control strategies have
failed'. Subsequently, MDA has received little attention until the introduction of
artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria
transmission by clearing the population of sexual stage parasites, gametocytes, prior to the
transmission season. Gametocytes are essential for propagation of the disease and elimination
of gametocytes will result in a reduction in malaria transmission. As a consequence, a
successful MDA will reduce the burden of disease in a population and is expected to have
little influence on the development of protective immunity in areas of low transmission
intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That
study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of
artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible
reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on
malaria transmission, the incomplete coverage, the relatively high transmission intensity in
the area and the migration of individuals between villages. Here, we propose to conduct an
MDA study in an area of very low malaria transmission intensity in Tanzania. We use the
highly active drug combination SP+AS (3 days) followed by a single dose of primaquine.
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