DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon

Information source: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria, Vivax; Malaria, Falciparum

Intervention: Pyrimethamine/sulfdoxine (Fansidar) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Walter Reed Army Institute of Research (WRAIR)

Official(s) and/or principal investigator(s):
Alan Magill, MD, Principal Investigator, Affiliation: Walter Reed Army Institute of Research (WRAIR)

Summary

The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar«) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. The study design was based on accepted WHO parasitological and clinical outcomes to determine the overall efficacy of Fansider and inform the Peruvian National Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line treatment for uncomplicated falciparum malaria in the Peruvian Amazon.

Clinical Details

Official title: Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar«) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.

Eligibility

Minimum age: 6 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pf monoinfection with asexual forms

- Parasite density of greater than 500 per mcl and less than 200 parasites per oil

immersion field (MINSA quantification of "4 plus")

- Age > 6 months

- Temperature greater than 38C (101F)

- Available and willing to return for follow-up

Exclusion Criteria:

- Presence of any of the following "danger" signs or symptoms suggestive of severe

malaria

- Not able to drink or breastfeed

- Repeated vomiting (unable to keep anything down)

- Convulsions during present illness

- Lethargic or unconscious state

- Unable to sit or stand up

- Respiratory distress

- Jaundice (observation) or dark urine (by history)

- Severe anemia (Hemoglobin < 5 g/dl)

- Hypotension (systolic BP < 80 mm Hg in adults and < 50 mm Hg in children under the

age of 5

- Presence of another significant illness or chronic disease

- Known pregnancy (by history)

- History of hypersensitivity to medication used in the test

Locations and Contacts

Naval Medical Research Center Detachment, Lima, Peru
Additional Information

Starting date: January 1998
Last updated: July 26, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017