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Trial record 76 of 1404 for:    Peru

Assessment of Artesunate/Mefloquine in the Peruvian Amazon (Artesunate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084602
Recruitment Status : Unknown
Verified March 2014 by Instituto Nacional de Salud. Peru.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2014
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
Naval Medical Research Unit No 6
Information provided by (Responsible Party):
Instituto Nacional de Salud. Peru

Brief Summary:

There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.

The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.


Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Artesunate Drug: Mefloquine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of in Vivo and in Vitro Efficacy of Combined Artesunate/Mefloquine Therapy for Treatment of Uncomplicated Plasmodium Falciparum Infection in the Peruvian Amazon
Study Start Date : June 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Artesunate/mefloquine
Orally administration of artesunate 4mg/Kg by three days Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day
Drug: Artesunate
Orally administration of artesunate 4mg/Kg by three days
Other Name: Distribuited by AC Farma

Drug: Mefloquine
Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day
Other Name: Distribuited by AC Farma




Primary Outcome Measures :
  1. Parasite clearance time [ Time Frame: up to 72 hours after administration of artesunate ]
    Parasite clearance time assessed by microscopy and quantitative PCR


Secondary Outcome Measures :
  1. Parasite reduction rates and ratios [ Time Frame: 24, 48 hours after the first administration of artesunate ]
    Parasite reduction rates and ratios assessed by microscopy and quantitative PCR

  2. Time for parasite count to fall [ Time Frame: at least 24 hours ]
    Time for parasite count to fall to 50%, 90% and 99% of initial parasite density

  3. Fever clearance time [ Time Frame: at least 24 hours ]
    Time taken for temperature to fall below 37˚C and remain there for at least 24 hours

  4. Gametocyte carriage rates [ Time Frame: up to 14 days since the first administration of artesunate ]
    Gametocyte carriage rates assessed in person weeks up to 14 days



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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 5 and 65 years old inclusive
  • Monoinfection of P. falciparum confirmed by microscopy
  • Documented fever (axillary temperature > 37.5°C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc)
  • Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (μl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement
  • Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old)
  • Willingness of the participant to return to the health facility for regular check-ups during the follow-up period of 42 days
  • Willingness of the participant to transfer to the Hospital de Apoyo Iquitos to start treatment

Exclusion Criteria:

  • Severe malaria signs (as defined by the World Health Organization):

    1. Cerebral malaria (irreversible coma)
    2. Severe anemia (hematocrit < 15%, or clinic signs)
    3. Clinic signs of kidney failure (e.g., serum creatinine > 3 mg/dL)
    4. Pulmonary edema
    5. Hypoglycemia (glucose in the blood <40mg/dL or clinic signs)
    6. Shock (PA systolic < 70 mm Hg in adults; < 50 in children)
    7. Spontaneous bleeding/Disseminated intravascular coagulation (CID)
    8. Recurrent generalized convulsions
    9. Acidemia/acidosis (clinic signs)
    10. Macroscopic hemoglobinuria
    11. Jaundice Laboratory tests for measuring some of these conditions may not be available at all study sites. If they are not, we will use clinical criteria of severe malaria at the discretion of the study physician
  • Background of other chronic or severe diseases (e.g., heart, kidney, liver diseases, HIV/AIDS, severe malnutrition), determined clinically by medical history and physical examination
  • Background of hypersensitivity to any of the drugs tested or used as an alternative treatment: AS, MQ, quinine or tetracycline/clindamycin
  • Gestation (based on a serum pregnancy test or medical history) or desire to become pregnant during the study period, or not using any family planning method while being sexually active (confirmed by urine pregnancy test)
  • Breastfeeding a child under 6 months old
  • Have received antimalarial drugs in the previous 7 days
  • Inability to eat or drink, vomiting (more than twice in the last 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand
  • Splenectomy background

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084602


Contacts
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Contact: Edward Smith, MSc (c) 011 - 511 - 614 - 4141 ext 215 edward.simth@med.navy.mil

Locations
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Peru
NAMRU 6 Not yet recruiting
Iquitos, Loreto, Peru, 5116
Contact: Salomon Durand, Master    011 - 5165 - 617- 6296 ext 2143    salomon.durand@gmail.com   
Principal Investigator: Salomon Durand, Master         
Sponsors and Collaborators
Instituto Nacional de Salud. Peru
Naval Medical Research Unit No 6
Investigators
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Principal Investigator: Salomon Durand, Master NAMRU 6

Publications:
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Responsible Party: Instituto Nacional de Salud. Peru
ClinicalTrials.gov Identifier: NCT02084602     History of Changes
Other Study ID Numbers: U.2012.0008
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: March 2014
Keywords provided by Instituto Nacional de Salud. Peru:
artesunate
mefloquine
falciparum
peruvian amazon
Additional relevant MeSH terms:
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Malaria, Falciparum
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics