Plasmodium FalciparumPhase 4NCT01775592
Plasmodium Falciparum Artemisinin Resistance Vietnam
A Phase 4 study testing Arterakin (DHA-PPQ) in people with Plasmodium Falciparum, run by National Institute of Malariology, Parasitology and Entomology, Vietnam at 1 site in Vietnam.
Trial summary
Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Plasmodium Falciparum
- What is being tested?
- Arterakin (DHA-PPQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: from 6 months of age;
- Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
- Mono-infection with P.falciparum with parasite density between 500-100,000/µl
- Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.
Who cannot join
- Mixed malaria infection;
- Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
- Concomitant acute illness necessitating specific treatment (antibiotics);
- Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
- Severe malnutrition;
- Danger signs:
Show all 23Show fewer
- not able to drink
- incontrollable vomiting
- recent history of convulsions (>1 in 24 hours)
- unconscious state; neurological impairment
- unable to sit or stand
- Signs of severe malaria:
- Cerebral malaria (unrousable coma)
- Severe anaemia (Htc< 15%)
- Renal failure (serum creatinine > 3 mg/dL)
- Pulmonary oedema;
- Hypoglycemia (<40mg/dL)
- Shock (systolic BP < 70 mmHg in adults, 50 in children)
- Spontaneous bleeding
- Repeat generalized convulsions
- Macroscopic haemoglobinuria
- Severe jaundice
- Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam
Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.
Read the detailed description
General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.
Specific objectives
- To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
- To determine the efficacy of DHA-PPQ at day 42 post-treatment.
- To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
- To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;
- Conditions
- Plasmodium Falciparum
- Being tested
- Arterakin (DHA-PPQ)
- Keywords
- P.f resistance
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterakin (DHA-PPQ)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arterakin | Other | Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - < 8 years: 1.0, 1.0, 1.0, 1.0 8 - < 15 years:1.5, 1.5, 1.5, 1.5
≥ 15 years:2.0, 2.0, 2.0, 2.0 Receives: Drug: Arterakin (DHA-PPQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite clearance time
Measured: Day 2-5
Secondary outcomes (2)
efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam
treatment failure or success at day 42
Measured: Day 42
in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province
MarkIII in vitro test
Measured: Day 3-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Malariology, Parasitology and Entomology, Vietnam
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
- Investigators
- Annette Erhart, MD, PhD, Principal investigator, ITM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775592
- Sponsor's protocol ID
- NIMPE - ITM
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thriemer K, Hong NV, Rosanas-Urgell A, Phuc BQ, Ha do M, Pockele E, Guetens P, Van NV, Duong TT, Amambua-Ngwa A, D'Alessandro U, Erhart A. Delayed parasite clearance after treatment with dihydroartemisinin-piperaquine in Plasmodium falciparum malaria patients in central Vietnam. Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15.
PubMed 25224002
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam
- ClinicalTrials.gov ID
- NCT01775592
- Acronym / sponsor ID
- NIMPE - ITM
- Conditions
- Plasmodium Falciparum
- Keywords
- P.f resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- National Institute of Malariology, Parasitology and Entomology, VietnamOther government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.
Detailed description
General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.
Specific objectives
- To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
- To determine the efficacy of DHA-PPQ at day 42 post-treatment.
- To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
- To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterakin | Other | Drug: Arterakin (DHA-PPQ)Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - < 8 years: 1.0, 1.0, 1.0, 1.0 8 - < 15 years:1.5, 1.5, 1.5, 1.5 ≥ 15 years:2.0, 2.0, 2.0, 2.0 |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: from 6 months of age;
- Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
- Mono-infection with P.falciparum with parasite density between 500-100,000/µl
- Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.
Key exclusion criteria (23 listed)
- Mixed malaria infection;
- Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
- Concomitant acute illness necessitating specific treatment (antibiotics);
- Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
- Severe malnutrition;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterakin (DHA-PPQ) | Drug | Arterakin |
Primary outcome
Parasite clearance time
Time frame: Day 2-5
2 secondary outcomes
efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam
Time frame: Day 42
in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province
Time frame: Day 3-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Derived from this study: PubMed 25224002Thriemer K, Hong NV, Rosanas-Urgell A, Phuc BQ, Ha do M, Pockele E, Guetens P, Van NV, Duong TT, Amambua-Ngwa A, D'Alessandro U, Erhart A. Delayed parasite clearance after treatment with dihydroartemisinin-piperaquine in Plasmodium falciparum malaria patients in central Vietnam. Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15.
Related trials for Plasmodium Falciparum
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Erhart, MD, PhD principal investigator
ITM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arterakin (DHA-PPQ) in people with Plasmodium Falciparum, run by National Institute of Malariology, Parasitology and Entomology, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite clearance time (time frame: Day 2-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.