Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.

The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).

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Detailed Description

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Conditions

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Malaria, Falciparum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sevuparin/DF02

Sevuparin/DF02 plus anti-malarial regimen (Malanil®)

Group Type EXPERIMENTAL

Sevuparin sodium + atovaquone/proquanil

Intervention Type DRUG

Sevuparin 4 times per day and malanil according to label

Control

Anti-malarial regimen (Malanil®) alone

Group Type ACTIVE_COMPARATOR

atovaquone/proquanil

Intervention Type DRUG

malanil according to label

Interventions

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Sevuparin sodium + atovaquone/proquanil

Sevuparin 4 times per day and malanil according to label

Intervention Type DRUG

atovaquone/proquanil

malanil according to label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
* Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
* Presence of fever defined as \> 38°C tympanic temperature or a history of fever within the last 24 hours

Exclusion Criteria

* Mixed infection with other Plasmodium species
* Any criteria of severe or complicated malaria as defined by the WHO, 2010
* Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
* Presence of significant anemia as defined by Hb \<8 g/dL or Hct \< 25%
* A platelet count \< 50,000/μL
* Presence of febrile conditions caused by diseases other than malaria

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No