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    Search our database: Under the CMU program, telephone communications must be conducted using monitored phone lines, be live-monitored by staff, are subject to recording, and must be in English only.

    Martin Howard had a 145, G 9. MQ was used as the comparator based on the recommendation of the FDA, as this was the only FDA-approved oral anti-malaria agent at the time.

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    MQ was expected to have high efficacy rates in all of the chosen study locations at the time of the study conduct. Giemsa-stained blood smears were read and interpreted by experienced microscopists who were blinded to all clinical information, including treatment allocation and the readings by the other microscopists.

    Microscopy results at the site guided subject management; any subject with persistent or recurrent parasitaemia during the follow-up period was treated with anti-malarial drugs according to local treatment guidelines and withdrawn from the study after documentation of clearance of parasitaemia.

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    For subjects who developed asexual parasitaemia after a period of clearance, paired blood blots from baseline and the time of recurrence were analysed to distinguish recrudescence from re-infection.

    Recrudescence was defined as the reappearance of asexual blood-stage parasites of the same genotype as Day 0 parasites, whereas re-infection was defined as infection by a different genotype.

  • Serum chemistry tests included children, urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, and marked phosphatase.
  • Finally, subjects were missed if they had not lived to in a malaria-endemic area for at least the previous year.
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  • Subjects were censored at the time of re-infection. Paired blood specimens, collected before treatment and at the time of recurrent asexual parasitaemia treatment failure, were evaluated for mutations in the P.

    For study 1134, molecular detection of the K 76 T mutation associated with CQ resistance was detected by means of a standardised real-time PCR-based diagnostic assay.

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  • In addition, specimens collected on Day 0 from subjects who responded to treatment also were analysed for pfcrt gene mutations. Study assessments All subjects were hospitalised and monitored until three consecutive blood smears were negative for asexual P.

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    Peripheral blood smears for parasite counts were obtained at eight-hour intervals until clearance was demonstrated, then on Day 7 and weekly thereafter through Day 42 to monitor recrudescence.

    Vital signs, clinical signs and symptoms, adverse events AEs, and concomitant medications were assessed for all subjects on each day of treatment Days 0, and 2 and at each post-therapy visit Days 7, 14, 21, 28, 35, and 42.

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    Clearance time comparisons up to Drive 7 were generated using Kaplan-Meier estimates.
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    Haematology and serum chemistry laboratory tests were performed at Baseline and Day 3 and at subsequent visits if clinically indicated.

    Haematology tests included red blood count, white blood count with differential, haemoglobin, haematocrit, and platelets.

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