MalariaPhase 4MalTreSuNCT02592408
A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan
A Phase 4 study testing ASP, SDPQ and 14DPQ in people with Malaria, run by Menzies School of Health Research at 2 sites in Sudan.
Trial summary
This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- ASP, SDPQ and 14DPQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesSudan
- Study dates
- Nov 2015to May 2016
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 months
- P. vivax or P. falciparum mono-infection or P. vivax / P. falciparum mixed infection
- Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
- Able to tolerate oral medication
- Able and willing to comply with the study protocol for the duration of the study
- Informed consent from the patient or from a parent or guardian in the case of children
Who cannot join
- Bodyweight ≤5kg
- Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient according to the definitions of WHO
- Presence of severe malnutrition
- Acute anaemia <8g/dL
- Regular medication, which may interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s)
- A positive pregnancy test or lactating.
Trial locations and contacts
2 sites in 1 country.
Sudan2 sites
Gizeria Slang Hospital
Khartoum, Khartoum State, 11111
New Halfa Hospital
New Halfa, Kassalla, 31112
About this study
Official title: A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.
- Conditions
- Malaria
- Being tested
- ASP, SDPQ, 14DPQ, 14DPQ on Day 42
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASPDrug
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
SDPQDrug
single dose primaquine on day 2
14DPQDrug
14 day primaquine starting on day 2
14DPQ on Day 42Drug
14 day primaquine starting on day 42
| Study group | Role | What they receive |
|---|---|---|
| Pf: ASP | Active comparator | In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) Receives: Drug: ASP |
| Pv: ASP + 14DPQ on day 2 | Active comparator | In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2 Receives: Drug: ASP; Drug: 14DPQ |
| Pf: ASP + SDPQ | Active comparator | In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2 Receives: Drug: ASP; Drug: SDPQ |
| Pv: ASP + 14DPQ on day 42 | Active comparator | In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42 Receives: Drug: ASP; Drug: 14DPQ on Day 42 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm
Measured: In the first 42 days
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
Measured: In the first 42 days
Secondary outcomes (8)
The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: on days 1,2,3
The proportion of patients with fever on day 1, 2 and 3 after treatment
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: on days 1, 2, 3
The proportion of patients with gametocytemia on any of the follow up dates
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: In the first 42 days
The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: In the first 42 days
The fractional change in Hb between baseline and day 7,14 and 16 (incl. proportion of patients with >25% drop in Hb between the time points) in vivax / mixed infection patients receiving PQ
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: on days 0, 7, 14 and 16
The proportion of patients with adverse and serious adverse events
Outcome measure is stratified for P. falciparum and P. vivax infections
Measured: In the first 42 days
The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count
Measured: at the end of 14DPQ treatment (day 16)
The distribution of G6PD activity among the study population
Measured: on day of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
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 MalariaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Khartoum
- Responsible party
- Sponsor
- Investigators
- Muzamil Mahdi, PhD, Principal investigator, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592408
- Sponsor's protocol ID
- MenziesSHR
- Acronym
- MalTreSu
- Status last verified
- Jan 2017
- First submitted
- 26 Oct 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamid MMA, Thriemer K, Elobied ME, Mahgoub NS, Boshara SA, Elsafi HMH, Gumaa SA, Hamid T, Abdelbagi H, Basheir HM, Marfurt J, Chen I, Gosling R, Price RN, Ley B. Low risk of recurrence following artesunate-Sulphadoxine-pyrimethamine plus primaquine for uncomplicated Plasmodium falciparum and Plasmodium vivax infections in the Republic of the Sudan. Malar J. 2018 Mar 16;17(1):117. doi: 10.1186/s12936-018-2266-9.
PubMed 29548285
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
- ClinicalTrials.gov ID
- NCT02592408
- Acronym / sponsor ID
- MalTreSu / MenziesSHR
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- University of Khartoum
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Oct 2015 (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.
This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pf: ASP | Active comparator | Drug: ASPIn falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) |
| Pv: ASP + 14DPQ on day 2 | Active comparator | Drug: ASP, Drug: 14DPQIn vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2 |
| Pf: ASP + SDPQ | Active comparator | Drug: ASP, Drug: SDPQIn falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2 |
| Pv: ASP + 14DPQ on day 42 | Active comparator | Drug: ASP, Drug: 14DPQ on Day 42In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42 |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 12 months
- P. vivax or P. falciparum mono-infection or P. vivax / P. falciparum mixed infection
- Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
- Able to tolerate oral medication
- Able and willing to comply with the study protocol for the duration of the study
Key exclusion criteria (7 listed)
- Bodyweight ≤5kg
- Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient according to the definitions of WHO
- Presence of severe malnutrition
- Acute anaemia <8g/dL
- Regular medication, which may interfere with antimalarial pharmacokinetics
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 |
|---|---|---|
| ASP3 days of artesunate sulfadoxine/pyrimethamine on days 0-2 | Drug | Pf: ASP, Pf: ASP + SDPQ, Pv: ASP + 14DPQ on day 2, Pv: ASP + 14DPQ on day 42 |
| SDPQsingle dose primaquine on day 2 | Drug | Pf: ASP + SDPQ |
| 14DPQ14 day primaquine starting on day 2 | Drug | Pv: ASP + 14DPQ on day 2 |
| 14DPQ on Day 4214 day primaquine starting on day 42 | Drug | Pv: ASP + 14DPQ on day 42 |
Primary outcome
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
Time frame: In the first 42 days
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
Time frame: In the first 42 days
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
8 secondary outcomes
The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
Time frame: on days 1,2,3
The proportion of patients with fever on day 1, 2 and 3 after treatment
Time frame: on days 1, 2, 3
The proportion of patients with gametocytemia on any of the follow up dates
Time frame: In the first 42 days
The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment
Time frame: In the first 42 days
The fractional change in Hb between baseline and day 7,14 and 16 (incl. proportion of patients with >25% drop in Hb between the time points) in vivax / mixed infection patients receiving PQ
Time frame: on days 0, 7, 14 and 16
The proportion of patients with adverse and serious adverse events
Time frame: In the first 42 days
The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count
Time frame: at the end of 14DPQ treatment (day 16)
The distribution of G6PD activity among the study population
Time frame: on day of enrolment
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 1 Feb 2017.
- Derived from this study: PubMed 29548285Hamid MMA, Thriemer K, Elobied ME, Mahgoub NS, Boshara SA, Elsafi HMH, Gumaa SA, Hamid T, Abdelbagi H, Basheir HM, Marfurt J, Chen I, Gosling R, Price RN, Ley B. Low risk of recurrence following artesunate-Sulphadoxine-pyrimethamine plus primaquine for uncomplicated Plasmodium falciparum and Plasmodium vivax infections in the Republic of the Sudan. Malar J. 2018 Mar 16;17(1):117. doi: 10.1186/s12936-018-2266-9.
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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.
Muzamil Mahdi, PhD principal investigator
University of Khartoum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ASP, SDPQ and 14DPQ in people with Malaria, run by Menzies School of Health Research at 2 sites in Sudan.
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 6 inclusion and 7 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sudan. 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?
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections (time frame: In the first 42 days). The study lists 2 primary outcomes in all. 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 NCT02592408, 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 1 Feb 2017.