Efficacy and safety of the combination dihydroartemisinin-piperaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Champasack province, Laos PDR

Phase 4

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12618001650280
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-05
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age between 5 months and above to 60 years old as maximum age;
- P. falciparum confirmed by microscopy;
-P. Falciparum parasitaemia of 1000-100,000/µl asexual forms;
-Presence of axillary temperature more than 37.5 °C or history of fever during the past 24 h;
-Ability to swallow oral medication;
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
-Informed consent from the patient or from a parent or guardian in the case of children aged less than 12 year old;
-Informed assent from any minor participant aged more than 12 years and less than 18 years old ;
-Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.

Exclusion Criteria

-presence of general danger signs in children aged under 5 months or signs of severe falciparum malaria according to the definitions of WHO
-weight under 5 kg;
-mixed or mono-infection with another Plasmodium species detected by microscopy;
-presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm);
-presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
-regular medication, which may interfere with antimalarial pharmacokinetics;
-history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
-Female patients of child-bearing age, defined as those who menstruate and who are sexually active, will be not included in the study, because they are always not honest to tell on their sexual intercourse experience, which also reflects local culture if they are not yet married.
-a positive pregnancy tested or lactating women; and
-Unable to or unwilling to take pregnancy test or to use contraception for women of child- bearing age and who are sexually active.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of treatment success confirmed by using blood smears for microscopy and dry blood spot for Polymerase Chain-Reaction (PCR). For the purposes of this study, treatment success is defined as patients who have an adequate clinical and parasitological response to treatment.<br><br>[42 days after treatment the primary timepoint patients will be assessed daily on Day0,1,2 and 3 and weekly thereafter ( D7,D14,D21,D28,D35) until Day 42<br>]

Secondary Outcome Measures

Name	Time	Method
Evaluate safety by the incidence of adverse events assessed by clinical observation of symptoms. For example: vomiting, abdominal pain, and rashes[Any time adverse events occur between Day 0 and Day 7]